IA #80-04 - REVISED 9/11/97, IMPORT ALERT #80-04, "SURVEILLANCE AND DETENTION
WITHOUT PHYSICAL EXAMINATION OF SURGEON'S AND OR PATIENT EXAMINATION GLOVES" -
ATTACHMENT A - 2/10/09, ATTACHMENT B - 8/24/07
(NOTE: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(s) at issue. It
does not create or confer any rights for or on any person, and does not
operate to bind FDA or the public.
REASON FOR
REISSUANCE: A new procedure was developed for detention without physical
examination of gloves manufactured by firms who repeatedly
import non-compliant products.
TYPE OF ALERT: Surveillance (Physical Examination), and Detention Without
Physical Examination
PRODUCT: Surgeon's and Patient Examination Gloves
PRODUCT CODE: 80LZA, 80FMC, 80LYY, 80LZC, 80LYZ, 79KGO
PAC: 82Z003
PROBLEM: Defective per 21 CFR 800.20 - Leaks, tears, mold, embedded
foreign objects
COUNTRY: Surveillance - All Countries - (ZZ)
Detention Without Physical Examination - See Attachments (A
& B)
MANUFACTURER/
SHIPPER: See Attachments (A & B)
MANUFACTURER/
SHIPPER ID#: N/A
IMPORTER'S
ID #: N/A
CHARGE: The article is subject to refusal of admission pursuant to
section 801(a)(3) in that it appears to contain
defects/holes [Adulteration, section 501(c).]_
When FDA has documented repeated violations, and the
manufacturer/shipper has been issued a Warning Letter and
listed in Attachment B of the Recidivist Policy describe
below, future shipments ma be detained charging the
following:
The article is subject to refusal of admission pursuant to
section 801(a)(1) in that it appears that the methods used
in, or the facilities and controls used for, the
manufacture, packaging, storage, or installation of the
device do not conform with Good Manufacturing Practices
[Adulteration, section 501(h), Good Manufacturing Practices,
Section 520(f).]
RECOMMENDING
OFFICE: Center for Devices and Radiological Health (CDRH)
REASON FOR
ALERT: CDRH has determined that many foreign manufacturers and
shippers of medical gloves have failed to consistently
provide medical gloves of adequate quality for distribution
in the U. S. Surgeon's and examination gloves are widely
used by health care professionals and others as a barrier to
blood-borne diseases and pathogens. Defective medical
gloves present a potential hazard to health for users as
well as patients. Therefore, continuous monitoring of these
medical gloves is needed.
GUIDANCE: Districts may detain without physical examination, all
shipments of surgeon's and patient examination gloves from
the manufacturers/shippers listed on the attachments to this
alert.
Surveillance sampling of other manufacturers/shipper's
surgeon's and patient examination gloves per the most recent
guidance is indicated.
NOTE: Because the presence of defects in medical gloves
represents a potential hazard to health, only one (1)
violative sample is needed to submit a recommendation for
detention without physical examination to the Division of
Import Operations & Policy (DIOP). DIOP has direct
reference authority for detention without physical
examination of these medical gloves. Violative medical
gloves are subject to RPM Chapter 9, Detention Without
Physical Examination, subchapter Recommendations Based on
One Sample.
The following strategy has been established to address those
maufacturers/shippers who are found to repeatedly ship
violative medical gloves to the U.S. (recidivist firms.)
Level 1 Detention (INDICATED BY * IN ATTACHMENT A)
When a district encounters a shipment of medical gloves
which is found violative for defects by FDA analysis, the
shipment should be detained and a recommendation for
detention without physical examination should be forwarded
to DIOP, HFC-170.
If the recommendation meets current guidance, the
manufacturer/shipper will be placed on attachment A with a
single asterisk(*), and subsequent medical glove shipments
from that manufacturer/shipper may be detained without
physical examination under this import alert. This is
referred to as Level 1 detention. The manufacturer/shipper
may obtain admission of subsequently detained shipments of
medical gloves by presenting evidence that the individual
shipments are not adulterated, such as sample analyses
performed by an independent testing laboratory, following
the sampling plan and test method contained in FDA guidance.
In order for the responsible manufacturer's/shipper's name
to be removed from attachment A, documentation should be
provided with sufficient evidence that their medical gloves
are not adulterated (for example, five consecutive non-
violative shipments analyzed as described in the preceding
paragraph may be considered adequate evidence for
manufacturers/shippers to be removed from Level 1
detention).
Level 2 Detention -- (Recidivist firms which are
currently on Level 1 detention, or which have been removed
from Level 1 detention) (INDICATED BY ** IN ATTACHMENT A)
If a manufacturer/shipper, while on Level 1 detention, has a
violative sample analyzed by a private laboratory, the
district should notify DIOP and submit supporting
documentation. DIOP will place the firm on Level 2 detention
and identify the manufacturer/shipper on attachment A with
two asterisks (**).
Similarly, if a manufacturer/shipper that has been removed
from Level 1 detention has a violative sample analyzed by
FDA within 24 months from the date they were removed from
Level 1 detention, the district should notify DIOP and
submit supporting documentation. DIOP will verify the
manufacturer/shipper was listed under Level 1 detention
during the past 24 months and if confirmed will place the
manufacturer/shipper on Level 2 detention and identify the
manufacturer/shipper on attachment A with two asterisks
(**).
DIOP will bring this action to the attention of CDRH.
Based on this second listing within 24 months, CDRH has
agreed to notify the foreign firm in writing of FDA's
concerns about potential deficiencies in the manufacturing
practices and process controls which may be affecting the
quality of the medical gloves shipped to the U.S. A copy
of the Good Manufacturing Practices (GMP) Regulations will
be provided with the letter for their information.
Once a manufacturer/shipper is placed on Level 2 detention,
FDA may need greater assurance that the medical gloves are
not adulterated before removing the manufacturer/shipper
from detention without physical examination status. For
example, 10 consecutive non-violative shipments, analyzed by
an independent testing laboratory, may be considered
adequate evidence that the manufacturer/shipper is shipping
medical gloves to the U.S. which are not adulterated. Other
types of evidence to remove the appearance of a violation
will be evaluated by CDRH on a case-by-case basis.
Level 3 Detention -- (Recidivist firms which are
currently on Level 2 detention, or which have been removed
from Level 2 detention) (** * IN ATTACHMENT A DENOTES A
WARNING LETTER IS BEING CONSIDERED BY CDRH)
If a manufacturer/shipper, while on Level 2 detention, has
another violative sample analyzed by an independent testing
laboratory, the district should notify DIOP and submit
supporting documentation.
Similarly, if a manufacturer/shipper removed from Level 2
detention has another violative sample analyzed by FDA
within 24 months from the date they were removed from Level
1 detention, or the date they were placed on Level 2
detention, DIOP will bring these instances to the attention
of CDRH.
Based on the failure of the manufacturer's/shipper's medical
gloves to pass FDA analysis [Section 501(c)] after being
listed on Level 2 detention, or having failed an independent
testing laboratory examination while under Level 2
detention, CDRH may then issue a Warning Letter to the firm.
Additionally, after reviewing the manufacturer/shipper's
export and inspectional history, CDRH may elect to charge
the firm for failure to conform with GMPs [Section 501(h)],
based on the recurring GMP deficiencies as revealed by the
repeated failures of analyses. If CDRH determines a warning
letter should issue to the foreign manufacturer/shipper,
DIOP will place the manufacturer/shipper on Level 3
detention (attachment B).
Non-violative analyses may not be sufficient to remove the
appearance of a violation for manufacturers/shippers on
attachment B. Manufacturers/shippers will remain on Level 3
detention until evidence is provided to CDRH which
demonstrates that the medical gloves are being manufactured
in accordance with Good Manufacturing Practices (for
example, an acceptable FDA inspection or a written
certification from the manufacturer/shipper together with
the results of an independent audit performed by a qualified
third party).
Once a foreign manufacturer/shipper satisfactorily
demonstrates that the apparent GMP deviations have been
corrected, the manufacturer/shipper will be removed from
attachment B and placed on attachment A under the Level 1
detention for individual shipment analysis to confirm their
medical gloves do not contain defects until they provide
adequate evidence to be removed from Level 1 detention (see
above).
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
443-3320 or 3007.
For questions concerning 21 CFR 800.20, CPG 7124.31, medical
glove labeling, or other compliance issues, contact CDRH,
Office of Compliance, Division of Enforcement II at (301)
594-4618.
SAMPLING: See 21 CFR 800.20(c) for sample plans.
All sizes should be represented as closely as feasible to
the proportion which they exist in the shipment, however,
exact statistical representation is not necessary. If the
sample is found violative, all sizes should be detained.
When an entry consists of only one size, attempt to collect
as many lot numbers as possible. For example, if during a
random sample collection three lot numbers are observed,
represent them all as subs within one sample. If the sample
is found violative, all lots should be detained.
If a shipment is detained based on the analysis of one lot
and subsequently it is learned that there were 10 lot
numbers present, the detention stands.
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging is required.
KEY WORDS: Gloves, defects, surgeon's, exam gloves, holes, tears,
embedded foreign objects
PREPARED BY: Fredda Shere-Valenti, DIOP, (301) 443-6553
Diane Goldsberry, CDRH/OC/DOEII (301) 594-4618
John Farnham, CDRH/OC/DOEII (301) 594-4618
DATE LOADED
INTO FIARS: September 11, 1997
ATTACHMENT A REVISED 2/10/09
* = Firm is on Level 1 Detention
** = Firm is on Level 2 Detention
*** = Firm is on Level 3 Detention
CANADA
FORMER ADDRESS
A.R. Medicom Corp. (Shipper) Examination Gloves
910 Begin Street 80F[][]MC
St. Laurent, Quebec H4M 2N5 80L[][]YY
Canada 80L[][]YZ
FEI# 3002324385 80L[][]ZA
ID# XQARMED910STL 80L[][]ZC
80N[][]PC
5/19/93
NEW ADDRESS
A.R. Medicom Corp
9404 Cote de Liesse Exam Gloves
Lachine, Quebec H8T 1A1 80F[][]MC
Canada 80L[][]YY
FEI# 3002324385 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
10/1/98
Hedy Canada Exam Gloves
R 1350 42nd Se 80F[][]MC
Calgary, Alberta T2G3V6 80L[][]YY
MID# XAHEDCAN1320CAL 80L[][]YZ
FEI# 3002807150 80L[][]ZA
80L[][]ZC
80N[][]PC
7/8/96
* WW Medical Supplies Inc. Examination Gloves
219 Connie Cres, Unit #4 80F[][]MC
Concord, Ontario 80L[][]YY
Canada L4K 1L7 80L[][]YZ
ID# XOWWMED219CON 80L[][]ZA
80L[][]ZC
80N[][]PC
5/19/93
CHINA, PEOPLE'S REPUBLIC
* Anbao Latex Factory Examination Gloves
Qiange Village 80F[][]MC
inzhaizi County 80L[][]YY
Ganjing District 80L[][]YZ
Dalian, China 80L[][]ZA
FEI# 1000254481 80L[][]ZC
80N[][]PC
4/3/00
Division of:
Sinochem Liaoning Import and Export
50 Youhad Road
Dalian, China
FEI# 1000464408
Anhui Provincial Medicines & Examination Gloves
Health Products 80F[][]MC
Import & Export Corporation 80L[][]YY
162 I\E 80L[][]YZ
Shanghai, PROC 80L[][]ZA
MID# CNANHPRO162ANH 80L[][]ZC
MID# CNANHPRO1625SHA 80N[][]PC
4/8/94
Changzhou Foreign Trade Corp. Examination Gloves
15 Xian Xue Street 80F[][]MC
Changzhou, Jiangsu, China 80L[][]YY
MID# CNCHAFOR15CHA 80L[][]YZ
MID# CNCHAFOR15JIA 80L[][]ZA
FEI# 100036802 80L[][]ZC
80N[][]PC
9/20/95
China Jiangsu Medicines and Examination Gloves
Health Products Import and Export Corp. 80F[][]MC
215-6 Zhongshan Street 80L[][]YY
Nanjing, China 80L[][]YZ
FEI# 1000174806 80L[][]ZA
MID# CNCHIJIA2156NAN 80L[][]ZC
80N[][]PC
2/20/96
China Meheco Qingdao Import and Examination Gloves
Export Corporation 80F[][]MC
48 Zhan Shan Da Road 80L[][]YY
Qingdao, Peoples Republic of China 80L[][]YZ
MID# CNCHIMEH48QIN 80L[][]ZA
80L[][]ZC
80N[][]PC
4/28/94
* Copious International, Inc. Vinyl Examination Gloves,
Wei 11th Road, Huada St., 80LYY, 80FMC, 80LYZ, 80LZA
Heyuan, Guangdong Province, 80LZC, 80NPC
China 12/16/08
FEI#3003753496
* E-Full Industrial Ltd. Examination Gloves
No. 1, Industrial Zone 80F[][]MC
Linqing, Shandong, China 80L[][]YY
FEI# 3004128020 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
3/11/04
* Evergreen Medical Products Exam Gloves
(Jiangxing) Co., Ltd. 80F[][]MC
1 Evergreen Rd, 80L[][]YY
Jingxing County 80L[][]YZ
Shijiazhuang City, China 80L[][]ZA
FEI# 3003381681 80L[][]ZC
80N[][]PC
2/16/05
Fujian Ming Sheng Ind. 12/24/92
Gloves
S. Xin Shi Road
Fujian, China
MID# CNFUJMIN187SAN
aka
Sanming Foreign Trade Corp. 7/23/93
187 Xin Shi Nan Road
Sanming, Fujian
China
MID#CNSANFOR187SAN
Guilin Latex Factory Examination Gloves
26 Shanghai St. Jiashan 80F[][]MC
Guilin, Guangxi, China (P.R.C.) 80L[][]YY
ID# CNGUILAT26GUI 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
6/9/93
* Great Glove (Xinghua) Examination Gloves Co., Ltd.
South of Wei Wu Road, 80LYY, 80FMC, 80LZA,
Economic Developing 80LYZ, 80LZC and 80NPC
District, 12/3/08
Xinghua, 225700
Jiangsu, China (Mainland)
FEI# 3006403560
SHIPPER:
Protective Industrial
Products Manufactory Ltd.
Flat 1-11, 6/F, Kar Wah
Industrial Building,
Yuen Long, New Territories,
Hong Kong
FEI# 3003395913
* Heyuan Hongli Industries, Inc. Examination Gloves
No. 2, Ming Zhu Industrial 80F[][]MC
Heyuan, Guang Dong 80L[][]YY
China 80L[][]YZ
FEI# 3003255494 80L[][]ZA
80L[][]ZC
80N[][]PC
5/25/06
Hubei Provincial Medicines Examination Gloves
& Health Products Import & 80F[][]MC
Export Corporation 80L[][]YY
No. 196 Jingwu Road 80L[][]YZ
Hankou, China 80L[][]ZA
MID# CNHUBPRO196HAN 80L[][]ZC
80N[][]PC
5/23/94
* Ideal Medical Industries Examination Gloves
7a 762 Baizhang East Road 80F[][]MC
Ningbo 80L[][]YY
China 80L[][]YZ
FEI# 3004134583 80L[][]ZA
80L[][]ZC
80N[][]PC
3/2/07
* Jiangsu Cureguard Glove Co., Vinyl Examination Gloves,
Ltd., No. 205 Jianling Road, 80LYY, 80FMC, 80LYZ, 80LZA
Suqian, Jiangsu Province, China 80LZC, 80NPC
FEI#3006534695 12/16/08
** Nantong Ruchang Latex Products Co., Ltd. Examination Gloves
HuanZhen Rudong County 80F[][]MC
Jiangsu, Province South 80L[][]YY
of the Huanzhen Bridge 80L[][]YZ
Nantong, Jiangsu, China 80L[][]ZA
FEI #1000286233 80L[][]ZC
80N[][]PC
2/16/05
Placed on Level II
9/13/05
* Ningbo Free Zone Chain Examination Gloves
Medical Products 80F[][]MC
Room B3-B4, FL 10, No. 72 80L[][]YY
Ma Yuan Road 80L[][]YZ
Ningbo, China 80L[][]ZA
FEI# 3005034090 80L[][]ZC
80N[][]PC
7/21/08
* Ningbo Tianshun Rubber Products Co., Ltd. Exam Gloves
Yushan Industrial Zone, Sanqishi, Yuyao 80F[][]MC
Ningbo, China 80L[][]YY
FEI# 3003897787 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
6/14/06
* Pinnacle Co, LTD. Vinyl Exam Gloves
No. 4-2-402 Hengsheng Guoji Park 80LYY, 80FMC, 80LZA
240 Renmin Road 80LYZ, 80LZC, 80NPC
Linzi, China 255410 2/6/09
FEI# 3006946173
Qingdao Shuang Die Latex Examination Gloves
Corporation 80F[][]MC
103 Tai Dong First Rd. 80L[][]YY
Qingdao, China 80L[][]YZ
ID# CNQINSHU103QIN 80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
Shangdong Medicines & Health Products Examination Gloves
Import & Export Corporation 80F[][]MC
Qingdao, PROC 80L[][]YY
MID# CNSHAMEDQIN 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
4/8/94
* Shanghai Champion Plastic Examination Gloves
Products Co., Ltd. 80F[][]MC
No. 8, New District, Zhu Hang Chen, 80L[][]YY
Jinshan District 80L[][]YZ
Shanghai, China 80L[][]ZA
FEI# 3003857909 80L[][]ZC
3002990238 80N[][]PC
1/12/07
** Shanghai Foremost Plastic Examination Gloves
Industrial Co., Ltd. 80F[][]MC
Yan Li River Bridge East, 80L[][]YY
Chexing Highway, Chedun Town 80L[][]YZ
Songjiang City, Shanghai, China 80L[][]ZA
FEI# 3003852635 80L[][]ZC
80N[][]PC
3/19/07
Shanghai-Foxboro Co., Ltd Examination Gloves
161 Caobao Road 80F[][]MC
Shanghai, China (P.R.C.) 80L[][]YY
ID# CNSHACO161SHA 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
6/9/93
Shanghai Latex Factory Examination Gloves
Changzheng, China 80F[][]MC
FEI# 1000360789 80L[][]YY
MID# CNSHALATCHA 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
7/6/95
Shanghai Medicines & Health Products Examination Gloves
27 Zhongsan Road 80F[][]MC
Shanghai, PROC 80L[][]YY
MID# CNSHAMED27SHA 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
4/8/94
Shanghai Strong Plastic Examination Gloves
Products Co., Ltd. 80F[][]MC
Dongjing Town, Songjiang County 80L[][]YY
Shanghai, China 80L[][]YZ
ID# CNSHASTRSON 80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
** Shanghai Walnut Latex Examination Gloves
Products Co., Ltd. 80F[][]MC
1700 Huangxing Road 80L[][]YY
Shanghai, China (Mainland) 80L[][]YZ
FEI# 1000435246 80L[][]ZA
80L[][]ZC
80N[][]PC
8/10/98
* Shijiazhuang Brethern Examination Gloves
Plastic Co. Ltd., 80F[][]MC
No. 205 Zhonghua South St, 80L[][]YY
Shijiazhuang, Hebei, 80L[][]YZ
China (Mainland) 80L[][]ZA
FEI# 3001146957 80L[][]ZC
80N[][]PC
10/8/08
* Shijiazhuang Dilly Plastics Examination Gloves
Product Co., Ltd. 80F[][]MC
No. 5 Zhuangyuan Road 80L[][]YY
Luquan City 80L[][]YZ
Shijiazhuang, China 80L[][]ZA
FEI# 3004134857 80L[][]ZC
80N[][]PC
2/26/04
** Shijiazhuang Holy Plastics Examination Gloves
AKA Shijiazhuang Dilly 80F[][]MC
Plastics Co., Inc. 80L[][]YY
No. 5, Zhuang Yuan Road 80L[][]YZ
Lu Quan City, Shijiazhuang 80L[][]ZA
FEI# 3004135724 80L[][]ZC
3002522395 80N[][]PC
11/27/07
* Shijiazhuang Manful Light Industrial Examination Gloves
Products Co., Ltd. 80F[][]MC
78 Cangshi Rd. 80L[][]YY
Jinzhou City, Hebei, China 80L[][]YZ
FEI# 3004606537 80L[][]ZA
80L[][]ZC
80N[][]PC
6/8/05
* Shijiazhuang Wally Examination Gloves
Plastic Co. Ltd., No. 78 80F[][]MC
Tonda Rd. Jinzhou City 80L[][]YY
Bebei, 052260, China 80L[][]YZ
(Mainland) 80L[][]ZA
FEI# 3003896660 80L[][]ZC
80N[][]PC
9/18/08
Corrected PC
10/21/08
* Shijiazhuang Winful Plastic Co., Ltd. Examination Gloves
No. 6 Cangshi 80F[][]MC
Jinzhou City, Hebei, China 80L[][]YY
FEI# 3004938797 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
2/28/08
* Sinochem Hebei Examination Gloves
Import/Export Corp. 80F[][]MC
No. 228, 2nd Section 80L[][]YY
Heping W. Road 80L[][]YZ
Shijiazhuang, China 80L[][]ZA
FEI# 1000640024 80L[][]ZC
80N[][]PC
11/25/98
* Surefine Ningbo Medcare Co. Ltd. Examination Gloves
Flat J-1, 15/F 80F[][]MC
No. 165 Baizhang Rd. 80L[][]YY
Ningbo, China 80L[][]YZ
FEI# 3005066582 80L[][]ZA
80L[][]ZC
80N[][]PC
9/23/05
* Suzhou Hengliang Imp & Exp Co. Ltd. Examination Gloves
6th Pl. Intnl. Economic Trade Mansion 80FMC, 80LYY, 80LZC
6 Xi Huan Rd 80LZA, 80NPC, 80LYZ
Suzhou, Jiangsu, China (Mainland) 7/20/05
FEI# 3004927510
Tianjin Tang Gu Latex Factory
Tang Gu, Tianjin Examination Gloves/
Peoples Republic of China 80F[][]MC
MID# CNTIATANTIA 80L[][]YY
FEI# 3675 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
9/27/95
* Tongruhn Medical Products Co., Ltd. Exam Gloves
88, Tongxing, Zhen'An District 80F[][]MC
Dandong, Liaoning, China 80L[][]YY
FEI# 3004117953 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
5/23/05
Wuxi Resin Gloves Factory Examination Gloves
Houqiao 80F[][]MC
Wuxi, Jingsu 214106, China 80L[][]YY
ID# CNWUXRESWUX 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
Zhangjiagang Fululia Exam Gloves
Rubber Plastic Co. Ltd 80F[][]MC
Xizhang Town Zhangjiagang City 80L[][]YY
Jiangsu Province 80L[][]YZ
China 80L[][]ZA
MID# CNZHAFULJIA 80L[][]ZC
FEI# 1000185441 80N[][]PC
7/8/96
Zhangjiagang Green Plastic Examination Gloves
Products Co. 80F[][]MC
Xizhang Town Zhangsiagang City 80L[][]YY
Jiangsu Province 80L[][]YZ
China 80L[][]ZA
FEI#1000573776 80L[][]ZC
80N[][]PC
6/13/97
* Zhenjiang Suhui Latex Products Co. Examination Gloves
Lianhe Chum, Yangzhong City 80F[][]MC
Yangzhong City, China 80L[][]YY
FEI# 1000538448 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
4/19/05
* Zibo Hengchang Plastic Examination Gloves
and Rubber Co., Ltd., 80LYZ, 80NPC, 80LYY,
Science Tec. Park in 80FMC, 80LZA, 80LZC
Zhangdian, Zibo City, 11/12/08
Shandong, China
FEI# 3004617435
* Zibo Hengde Plastic Examination Gloves
& Rubber Products Co. Ltd. 80FMC, 80LYY
Zhangdian District, 80LYZ, 80LZA
Science/Tec. Park of Zibo, 80LZC, 80NPC
Shandong, China 2/5/09
FEI# 3006540060
* Zibo Hongye Shanqin Plastic Examination Gloves
And Rubber Co., Ltd. 80F[][]MC
The Developing Technical District 80L[][]YY
Cross of Jiqing & Zhangtian Expwy. 80L[][]YZ
Zibo City, China 80L[][]ZA
FEI# 3006897004 80L[][]ZC
80N[][]PC
9/3/08
* Zi Bo Wang Plastic & Rubber Products Co. Ltd Exam Gloves
Liwang Village, Zhoujia Town 80F[][]MC
Huantai County 80L[][]YY
Zibo City, Shandong 80L[][]YZ
FEI# 3003851053 80L[][]ZA
80L[][]ZC
80N[][]PC
4/16/03
* Zibo Zhuangyuan Plastic & Rubber Examination Gloves
Co., Ltd. 80FMC, 80LZA, 80LYZ, 80LZC,
The Developing Tech. District 80LYY, 80NPC
Cross of Jiqing and Zhangtian Expwy. 01/25/07
Zibo City, China
FEI #3004938810
COLUMBIA (CO)
* Glormed Colombia S.A Vinyl Exam Gloves
Mamonal Km. 9 80LYY, 80FMC, 80LZA
Zona Franca 80LYZ, 80LZC and 80NPC
Cartagena, Colombia 2/6/09
FEI# 3006543087
DENMARK
Danpren Gloves A/S All Surgical Gloves
Roholmusvej 15 6/20/94
DK 2620
Albertslund, Denmark
HONG KONG
Asino Industrial Company Exam Gloves
Room 203 Hing Wah Industrial Building 80F[][]MC
Hi Yip Street 80L[][]YY
Yuen Long, Hong Kong 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
6/20/94
Chun Yip Plastics Ltd. Exam Gloves
603-609 Castle Peak Road 80F[][]MC
Tsuen Wan, Hong Kong 80L[][]YY
ID# HKCHUYIP6036TSE 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
6/10/93
Chung Yee Industries Limited (Shpr) Examination Gloves
No. 1 Great George Street 80F[][]MC
Island Centre, 80L[][]YY
Causeway Bay, Hong Kong 80L[][]YZ
ID# HKCHUYEE1CA 80L[][]ZA
80L[][]ZC
80N[][]PC
6/9/93
Cico Engineering Co., Ltd. (Shipper) Examination Gloves
63 Mody Road (Manufactured in China,
Tusa Sha Tsui Manufacturer Unknown)
Kowloon, Hong Kong 80F[][]MC
ID# HKCICENG63TUS 80L[][]YY
80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
David Trading Co. Exam Gloves
17 D Verdant Court 80F[][]MC
Discovery Bay, Hong Kong 80L[][]YY
80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
2/21/92
David Trading Co. Gloves
171-172 Gloucester Road 2/21/92
Hong Kong, Hong Kong
* E-Full Industrial Ltd. Examination Gloves
20 Wang Hoi Road, 1/F. 80LYY, 80LZA, 80FMC,
Yeung Yiu Chung No. 8 Indus. 80LYZ, 80LZC, 80NPC
Kowloon Bay 5/3/06
Hong Kong
FEI# 7576
* General Merchandise Company Examination Gloves
Units 1-7, 17-20 80LYY, 80FMC, 80LYZ,
3/F Kar Wah Industrial Bldg 80LZA, 80LZC, 80NPC
Hei Yip Street, 7/18/00
Yuen Long, Hong Kong
FEI #3003061833
Guangzhou Rubber Goods Factory Examination Gloves
aka E-Full Industrial Ltd. 80LYY, 80FMC, 80NPC
1/F., Yeung Yiu Chung No. 3 80LYZ, 80LZA, 80LZC
Industrial Building, 20 Wang Hoi Road 9/8/99
Kowloon Bay, Hong Kong
FEI# 7576
FEI# 3002423344
Hale Sun Inc. Examination Gloves
Abba Commercial Centre 80F[][]MC
Aberdeem Main Road 80L[][]YY
Hong Kong 80L[][]YZ
MID# HKHALSUNHON 80L[][]ZA
80L[][]ZC
80N[][]PC
8/5/93
(Shipper For Trans Ancient
Trading Co., Taiwan)
* Protective Industrial Products Examination Gloves
Manufactory Ltd. 80F[][]MC
Flat 1-11, 6F, Kar Wah Industrial Bldg. 80L[][]YY
Y.L.T.L. 356 80L[][]YZ
Yuen Long, N.T. 80L[][]ZA
Hong Kong 80L[][]ZC
FEI# 3002816627 80N[][]PC
10/4/99
Ricehill Enterprises Ltd.
(Distributor)
703, Sincere Building
173 Des Voeux Road
Central, Hong Kong
ID# HKRICENT703CEN
Sonley Glove Manufacturer (Factory) Examination Gloves
Units Nos. 1-7, 17-20 80F[][]MC
3/FL Kar Wah Industrial Bldg. 80L[][]YY
Hei Yip Street 80L[][]YZ
Tuen Long Nt, Hong Kong 80L[][]ZA
ID# HKSONGLO1720TUE 80L[][]ZC
80N[][]PC
3/25/93
Sonley Glove Manufacturer (Office)
178/Fl Best-o-Best Comercial
Centre 32-36, Ferry Street
P.O. Box 74281, Kowloon,
Central Hong Kong
ID# HKSONGLO7428KOW
INDIA
Asian Latex Limited Exam Gloves
Yogeshwar 80F[][]MC
M-2 Connaught Place 80L[][]YY
New Delhi 110001 80L[][]YZ
India 80L[][]ZA
FEI# 1000156445 80L[][]ZC
MID# INASILAT2NEW 80N[][]PC
11/27/96
Beekay Hygiene Products Examination Gloves
Unit of Bakhtawar Singh Balkrishan Ltd. 80F[][]MC
446 Sector-C 80L[][]YY
Uria Industrial Area 80L[][]YZ
Raipur 493 221, India 80L[][]ZA
ID# INBEEHYG446RAI 80L[][]ZC
80N[][]PC
3/25/93
Bright Rubber Industries (P) Ltd. Examination Gloves
B 80-84, Sector 8 80F[][]MC
Noida-201301 (Ghaziabad) U.P. 80L[][]YY
India 80L[][]YZ
MID# INBRIRUB8084NOI 80L[][]ZA
80L[][]ZC
80N[][]PC
12/3/93
Digiflex India Limited Exam Gloves
55 & 58 D, N.E.P.Z., Nodia 80F[][]MC
Ghaziabad, (U.P.) 80L[][]YY
India 80L[][]YZ
FEI# 1000146803 80L[][]ZA
ID# INDIGIND55NOI 80L[][]ZC
80N[][]PC
1/24/97
* Fitco India Examination Gloves
1 Skyline Habitat 80F[][]MC
Kochi, India 682030 80L[][]YY
FEI# 3001132666 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
6/3/98
(M/S Glove (India Pvt. Ltd.) Examination Gloves
C-7 M.E.P.Z. 80F[][]MC
Tambaram, Madras, India 80L[][]YY
ID# INMSGLO7TAM 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
7/29/92
Goodluck Marketing Private Limited Examination Gloves
106, Harikrupa Chambers PRODUCT CODE: 80LYY
B/D National Chambers, Ashram Road
Ahmedabad - 380 009
Gujarat, INDIA
FEI# 1000631370
5/12/97
Gujarat Health Care, Ltd. Examination Gloves
Village Masma, Tal: Olpad 80F[][]MC
Surat, Gujarat, India 80L[][]YY
FEI# 1000435495 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
11/7/95
M/S. Kerala Rubbers & Reclaims (P) Ltd. Examination Gloves
21, Cochin Export Processing Zone 80F[][]MC
Cochin, Kerala, India 80L[][]YY
ID# INMSKER21COC 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
Overseas Latex Pvt. Ltd. Examination Gloves
Plot No. 5 80F[][]MC
Cochin Export Processing Zone 80L[][]YY
Cochin, India 80L[][]YZ
ID# INOVELAT5COC 80L[][]ZA
80L[][]ZC
80N[][]PC
5/5/93
OFFICE:
Perfect Latex Pvt. Ltd. 12/3/93
A-1, Preet Vihar
Delhi-110092, India
MID# INPERLAT1DEL
FACTORY:
Perfect Latex Pvt. Ltd. Examination Gloves
23, NEPZ, NOIDA, 20135, U.P. 80F[][]MC
India 80L[][]YY
MID# INPERLAT23NOI 80L[][]YZ
Bombay, India 80L[][]ZA
MID# INUNILAT402BOM 80L[][]ZC
80N[][]PC
12/3/93
RFB Latex Private Limited 7/21/92
Plot 24, Noida Export Processing Zone
Noida-Dadri Rd., Phase II, Dist T
Gautam Budh Nagar, India
FEI# 3002808012
Sai Latex Private Limited Examination Gloves
Plot Nos. A-5, 6,7 Madras Export 80F[][]MC
Processing Zone 80L[][]YY
Tambaram, Madras - 600 045, India 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
9/16/94
Techni Bharathi Exports (Shipper)
Palackal Buildings
Premier Junction
Kalamassery 683
104 Cochin, Kerala, India
ID# INTECBHA683COC
Zoetic Polymers Pvt. Ltd. Examination Gloves
Plot 18, Cochin Export 80F[][]MC
Kakkana, Cochin, India 682-030 80L[][]YY
80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
2/3/93
INDONESIA
* Indoraya Everlast Exam Gloves
Jl Jend Sudirman Kav 25 80F[][]MC
Jakarta, Indonesia 80L[][]YY
FEI# 1000617827 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
5/28/98
Marganirmala Examination Gloves
Jarkata, Indonesia 80F[][]MC
ID# IDMARJAR 80L[][]YY
80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
6/9/93
** PT Berlian Glovindo
Jin. Sutomo Ujung 96 Exam Gloves
Medan 20235, North Sumatra 80FMC, 80LYY, 80LYZ, 80LZA
Indonesia 80LZC, 80NPC
FEI# 3003028381 6/2/05
Added to level 2
1/6/06
P.T. Daifatex Indah Examination Gloves
J.L. Cirangrang Barat 188 80F[][]MC
Bandung, Indonesia 80L[][]YY
ID# IDPTDAI188BAN 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
P.T. Dwilatex Glovindo Exam Gloves
JL. H.O.B. Cokroaminoto No. 221 80F[][]MC
Yogyakarta, Indonesia 80L[][]YY
80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
10/5/93
PT Indolex Karya Jakarta Examination Gloves
Krekot Jaya Molek Blok E/10 80F[][]MC
Jakarta Pusat, Indonesia 80L[][]YY
MID# IDPTIND10JAK 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
4/8/94
Factory:
JI. Industry Raya IV
Blok Ad No. 218
Jatake Tangerang, Indonesia
MID# IDJIIND218JAT
** Pt. Indorub Nusaraya Examination Gloves
Jl. Batang Kuis Psr 9 Harapan 88 80F[][]MC
Jl. Semarang No. 105/16 80L[][]YY
Medan, Sumatera Utara 80L[][]YZ
Indonesia 80L[][]ZA
FEI #1000261016 80L[][]ZC
80N[][]PC
6/30/06
*** Placed on Level II 10/3/06 ***
P.T. Indotama Megah Indah
Rubber, Indonesia
P.T. Kareisindo Marga Nirmala Examination Gloves
J1 Raya Pandaan Km. No. 43 80F[][]MC
Surabaya, Indonesia 80L[][]YY
ID# IDPTKAR43SUR 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
* P.T. Saptindo Surgical Sterile Latex Surgical Gloves
Saptindo Surgica P.T. Product Code: 79K[][]GO
Parman Kav 12slipi Class I
Jakarta, Indonesia 11/18/97
FEI# 1000397725
PT Surya Milani Plastic Utama Examination Gloves
Gedung Perkantoran Central Bungur 80F[][]MC
JL Bungur Besar No 38 J 80L[][]YY
Jakarta Pusat, Indonesia 80L[][]YZ
FEI# 1000622893 80L[][]ZA
80L[][]ZC
80N[][]PC
9/26/96
* PT. Tata Rubberindo Industries Examination Gloves
Jl. Raya Serang Km.13.8 80FMC, 80LYZ, 80NPC,
Cikupa, Tangerang 80LYY, 80LZC, 80LZA
Indonesia 4/6/06
FEI# 3000289768
P.T. Trihasta Loka Persada Examination Gloves
Jalan Kasir 2 No. 11 80F[][]MC
Pasar Kemis Tancerang, Indonesia 80L[][]YY
80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
11/21/94
KOREA
Sung Il Industrial Co., Ltd. Examination Gloves
a.k.a. Chung & Yong Co. Ltd. 80F[][]MC
C.P.O. Box 8578 80L[][]YY
Seoul, Korea 80L[][]YZ
MID# KRSUNIL8578SEO 80L[][]ZA
MID# KRCHUYON8578SEO 80L[][]ZC
80N[][]PC
10/28/92
MALAYSIA
AEK Rubber Product SDN. BHD Examination Gloves
Lot 1919 Jalan Bukit Kemuning 80F[][]MC
42450 Klang, Selango Ehsan 80L[][]YY
Malaysia 80L[][]YZ
FEI# 1000111859 80L[][]ZA
80L[][]ZC
80N[][]PC
12/8/92
Asiatic Burnet Dipped Products Examination Gloves
Lot 6, Jalan P/2A 80F[][]MC
Bangi Industrial Estate 80L[][]YY
Darul Ehsan, Malaysia 80L[][]YZ
ID# MYASIBURGDAR 80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
* Balak Rubber Examination Gloves
(Malaysia) SDN Berhad 80F[][]MC
Lot 478 & 479 Jalan 80L[][]YY
Simpang Balak, 4300 80L[][]YZ
Kajang, Selangor Darul Ehsan 80L[][]ZA
Malaysia 80L[][]ZC
FEI# 1000167546 80N[][]PC
8/11/98
* Betelcare SDN BHD Examination Gloves
Lot 3342, Jalan Keretapi Lama, 80FMC, 80LYY
7.5 Mile, Off Jalan Kapar, 80LYZ, 80LZA
Kapar, Sekangor Darul 80LZC, 80NPC
Ehsan, Malaysia 2/5/09
FEI# 3005431522
Boston & Pacific (Malaysia)
Sdn. Bhd. 12/7/90
Kulim Industrial Estate
P.O. Box 38, 09000 Kulim
Kedah, W. Malaysia
Bright Holdings SDN BH Examination Gloves
8 Jalan SS13/3a Subang JA 475 80F[][]MC
Petaling Jaya 80L[][]YY
Malaysia 80L[][]YZ
MID# MYBRIHOL475PET 80L[][]ZA
80L[][]ZC
80N[][]PC
11/3/94
Consolex Corporation, SDN.BHD. (Shipper) 9/28/92
40000 Shah Alam
Selangor Darui Ehsan
Malaysia
Clydesdale Industries SDN BHD Examination Gloves
Lot 478, Jalan Simpang Balak 80F[][]MC
Off Batu 13, Jalan Cheras 80L[][]YY
43000 Kajang, Selangor D.E. 80L[][]YZ
Malaysia 80L[][]ZA
FEI# 1000414801 80L[][]ZC
MID# MYCLYIND478KAJ 80N[][]PC
3/4/97
* Cymun Development Sdn. Bhd. Examination Gloves
Lot 32674 Batu 3 Jalan Jelapang 80F[][]MC
Perak, Malaysia 31200 80L[][]YY
FEI# 3003662661 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
2/10/03
Dispotex Industries Sdn. Bhd. Exam Gloves
No. 13, Jalan Tandang 80F[][]MC
46050 Petaling Jaya 80L[][]YY
Selangor Darul Ehsan 80L[][]YZ
Malaysia 80L[][]ZA
FEI# 1000303848 80L[][]ZC
ID# MYDISIND13PET 80N[][]PC
12/18/95
EAC Rubber Company M SDN BHD Examination Gloves
a Subsidiary of the East Atlantic Co. 80F[][]MC
1A Jalan 205 80L[][]YY
46050 Petaling Jaya 80L[][]YZ
Malaysia 80L[][]ZA
MID# MYEACRUB205PET 80L[][]ZC
80N[][]PC
2/14/94
Formtex Medical SDN. DHD. Examination Gloves
Klang 80F[][]MC
Malaysia 80L[][]YY
FEI# 3000273853 80L[][]YZ
FEI# 3000283278 80L[][]ZA
80L[][]ZC
80N[][]PC
7/21/97
Ganda Yakin SDN. BHD Examination Gloves
Suite 18B, 18th Floor, Office Tower 80F[][]MC
Kompleks Nagaria, Malaysia 80L[][]YY
ID# MYGANYAK18KUA 80L[][]YZ
ID# MYGANYAKUNK 80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
* Ganz Industries Sdn. Bhd. Examination Gloves
46-B Jalan Desa Baktitanam Desa 80F[][]MC
off Jalan Kelang Lamma 80L[][]YY
Kuala Lumpur 80L[][]YZ
Malaysia 80L[][]ZA
FEI# 3000193727 80L[][]ZC
80N[][]PC
3/11/99
** Glovco (M) Sdn Bhd, Lot Examination Gloves
760, Jalan Haji Sirat, 80L[][]YY, 80F[][]MC, 80L[][]YZ
42100 Klang Selangor, 80L[][]ZA, 80L[][]ZC, 80N[][]PC
Darul Ehsan, Malaysia 11/9/06
FEI# 3001441743
Placed on Level 2
10/29/07
* Handsafe Products Sdn. Bhd. Examination Gloves
Lot 6021, Kawasan Perindustrian 80LYY, 80LZA, 80LZC,
Bukit Kakri, Muar, 80LYZ, 80FMC, 80NPC
Johor, 84200, Malaysia 3/25/04
FEI# 1000604230
* Highactive Sdn Bhd Examination Gloves
Lot 12-B, Industrial Area, 80LYY, 80FMC, 80NPC
6 1/2 Miles 80LYZ, 80LZA, 80LZC
Jalan Kapong 2/17/00
52000 Kuala Lumpur
Malaysia
FEI# 3002853663
** Influx Pacific SDN BHD Examination Gloves
Lot 61 Air Keroh Ind Est Powder Free - 3/22/94
Melaka Powdered - 4/3/98
Malaysia 75720 80F[][]MC
MID# MYINFPAC61MEL 80L[][]YY
MID# MYINFMAN61MAL 80L[][]YZ
MID# MYINFPAC7572MAL 80L[][]ZA
FEI# 1000144099 80L[][]ZC
80N[][]PC
Level 2 ** Detention 2/3/99
* JK Rubber Products Sdn. Bhd. Examination Gloves
Lot 2247D, Jalan Sengkang, Sengkang 80F[][]MC
81000 Lulai, Johore, W. Malaysia 80L[][]YY
FEI# 3003304948 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
7/3/01
* Ki-Kepong Rubber Products Sdn Bhd Examination Gloves
aka Masif Latex Products Sdn Bhd 80FMC, 80LYY, 80LYZ, 80LZA
Ladang Pinji, Bahagian Sengat 80LZC, 80NPC
31300 Kampung Kepayang 4/19/06
Ipoh, Perak Darul Ridzuan
Malaysia
FEI# 3003635929 Name and address change
FEI# 3000292909 12/1/06
** Malaysian Healthcare Sdn Bhd Patient Examination Gloves
No. 34 Jalan PJS 11/7 80LYY, 80FMC, 80LYZ, 80LZA
Bandar Sunway 80LZC, 80PNC
46150 Petaling Jaya 12/6/00
Selangor, Malaysia
FEI# 3002646488
* Poly Arena Sdn. Bhd Examination Gloves
No. 24, Jalan Jasmine 5 80LYY, 80FMC, 80LZA, 80LZC
Tasman Jasmine 80LYZ, 80PNC
23000 Kajang Selangor Darul Ehsan 8/7/00
Malaysia
FEI# 3003020590
Powercrest (M) SDN. BHD. Examination Gloves
Lot 975, 3rd Mile, Jalan Kapar 80F[][]MC
P.O. Box 75, 41700 Klang 80L[][]YY
Selangor, Malaysia 80L[][]YZ
MID# MYPOWSDN4170SEL 80L[][]ZA
FEI# 1000311910 80L[][]ZC
80N[][]PC
* Protection Gloves Sdn. Bhd. Examination Gloves
Lot No. 236, Batu 2 1/2 80FMC, 80LYY, 80LZC,
Jalan Yong Pang 80LZA, 80LYZ,80NPC
Jokor, Malaysia 11/6/03
FEI# 3001735646
* Quality Latex Corp. Sdn. Bhd. Examination Gloves
18-20 Jalan Kilang 2 80FMC, 80LZA, 80LYZ, 80LZC,
Taman Pertama 80LYY, 80NPC
Ipoh, Perak, Malaysia 10/15/07
FEI# 3860
3001246109
* Seltom Pacific Sdn. Bhd. Examination Gloves
Lot PT 153 80FMC, 80LZA, 80LYZ, 80LZC,
Kawasan Perusahaan Beranang 80LYY, 80NPC
Mukim Beranang 6/27/02
Selangor, Malaysia 43700
FEI# 3003655267 Address Change
9/23/04
* Shiraishi (Malaysia) SDN BHD Exam Gloves
17-3 Jolan 14/22 80F[][]MC
The Right Angle 80L[][]YY
46100 Petaling Jaya, 80L[][]YZ
Selangor, Malaysia 80L[][]ZA
FEI# 3003534526 80L[][]ZC
80N[][]PC
10/28/03
Sinetimed Latex SDN. BHD Examination Gloves
Lot 57 & 8, Lorang Kilang 15 80F[][]MC
Tupai Light Industrial Area 80L[][]YY
34000 Taiping, Perak 80L[][]YZ
Malaysia 80L[][]ZA
FEI# 1000212624 80L[][]ZC
80N[][]PC
6/6/97
South Pacific Chemical Industries Examination Gloves
SDN BHD 80F[][]MC
No. 64-66, 2nd Floor, 80L[][]YY
Bangunan Jurukur 80L[][]YZ
Jalan 52/4, 46200 Petaling Jaya 80L[][]ZA
Darul Ehsan 80L[][]ZC
Selangor, Malaysia 80N[][]PC
ID# MYSOUPAC4620DAR 2/3/93
Stermed Industries SDN Bhd Examination Gloves
Lot 4209, Jalan Bakariah 80F[][]MC
Johor 84000 80L[][]YY
Malaysia 80L[][]YZ
FEI# 1000251953 80L[][]ZA
MID# MYSTEIND8400JOH 80L[][]ZC
80N[][]PC
7/21/95
Taiping Naga Rubbex Exam Gloves
Loy 6706, Jaln Sekolan, 80F[][]MC
Rantau Panjang, 3 3/4 miles, 80L[][]YY
Jalan Kapar 41400 80L[][]YZ
Kelang, Selangor Dakul Ehsan, 80L[][]ZA
Malaysia 80L[][]ZC
ID# MYTAINAG70KEL 80N[][]PC
12/8/92
Wescorp Industries, SDN. BHD. (Mfr.) Examination Gloves
Malaysia 80F[][]MC
Tri Ray SDN BHD 80L[][]YY
50000 Kuola Lupur 80L[][]YZ
Malaysia 80L[][]ZA
80L[][]ZC
80N[][]PC
9/28/92
MEXICO
* Derivados De Gasa Surgeon's gloves
Avenue Henry Ford, No. 366 SEE IMPORT ALERT #89-04
Del Gustavo A. Madero 80N[][]PD
07850, Mexico D.F. (Mexico 79K[][]GO
City), Mexico 3/10/94
* Derivados De Gasa is on automatic detention under Import Alert
#89-04 for failure to meet GMP's. The firm is listed here only
to preclude inadvertent release of entries. GMP charges should
be used for detentions.
Guantes Quirurgicos S.A.* Surgeon's gloves
de C.V. Av. Centenario No. 15 SEE IMPORT ALERT #89-04
62500 Civac Jiutepec 80N[][]PD
Cuernavaca, Moreles, Mexico 79K[][]GO
* Guantes Quirurgicos S.A. is on automatic detention under Import
Alert #89-04 for failure to meet GMP's. The firm is listed here
only to preclude inadvertent release of entries. GMP charges
should be used for detentions.
* Supertex Industrial SA De CV Examination Gloves
Carretera A Sosques 80F[][]MC
De San Isidro No. 1136 80L[][]YY
Zapopan, Jalisco 80L[][]YZ
Mexico 80L[][]ZA
FEI# 3001166250 80L[][]ZC
80N[][]PC
SEE IMPORT ALERT #89-04
9/14/98
* Supertex Industrial SA De CV is on automatic detention under Import
Alert #89-04 for failure to meet GMP's. The firm is listed here
only to preclude inadvertent release of entries. GMP charges
should be used for detentions.
PHILIPPINES
Midas International Development Co. Exam Gloves
103 E. Rodriguez Avenue 80F[][]MC
Ugong, Pasig, Metro Manila 80L[][]YY
Philippines 80L[][]YZ
MID# PHMIDINT103MET 80L[][]ZA
80L[][]ZC
80N[][]PC
2/23/94
SINGAPORE
G. Premjee Trading Pte. Ltd.
24 Raffles Place
#25-04 Clifford Centre, Singapore 0104
ID# SGPRETRA2504SIN
SRI LANKA
Latexam Gloves (Private) Ltd. Examination Gloves
344 Grandpass Road 80F[][]MC
Colombo 14, Sri Lanka 80L[][]YY
ID# LKLATGLO344COL 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
4/16/93
TAIWAN
Atico, Ltd.
Taiwan
CHC Hardware Co. Inc.
Taiwan
Chinese Product Promotion
Taiwan
Dan Co., Ltd. 9/3/92
A/K/A Dantex Glove Co 9/21/92 added
Suite 1005, No. 148 Examination Gloves
Section 4, Chung Hsaiao 80F[][]MC
East Road 80L[][]YY
Taipei, Taiwan 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
Daansen
Taipei, Taiwan
Daw Shin Industrial
Taiwan
1st Trust Industrial Corp
10th floor #172
Hsin_Yi Rd., Sec. 4
Taipei 10657, Taiwan
* Excellence Enterprise Co. Ltd. Patient Examination Gloves
No. 13, Chu Tsun Li 80F[][]MC
Puh Tzu City 80L[][]YY
Chia Yi Hsien, Taiwan R.O.C. 80L[][]YZ
FEI# 3003123198 80L[][]ZA
80L[][]ZC
80N[][]PC
6/18/01
* Evergreen Medical Exam Gloves
Products Co. Ltd. 80LYY, 80LZA, 80FMC
No. 1 Evergreen Road 80LYZ, 80LZC, 80NPC
The Nort of Beishimen Village 09/22/04
Xiaozuo Town
Jingxing County
Taiwan
FEI# 3004428435
* Gain Honor Development Limited Examination Gloves
Rm. 3, 5 th. Floor, No. 78 80F[][]MC
Fushin S. Rd. 80L[][]YY
Sec. 1, Taipei, Taiwan, R.O.C 80L[][]YZ
FEI# 1000655943 80L[][]ZA
80L[][]ZC
80N[][]PC
4/12/99
Goldeneyes Corp
Taiwan
** Hsing Yi Plastic Processing Co. Examination Gloves
No. 108-1 Der Jia Li 80F[][]MC
Put-Zu City 80L[][]YY
Chia-Yi Shien 80L[][]YZ
Taiwan 80L[][]ZA
FEI# 3001622651 80L[][]ZC
80N[][]PC
5/4/00
LCL Taiwan & Co., Ltd. Examination Gloves
No. 166-20 Riao-Pu-Li Matou Chen 80F[][]MC
Taiwan Hsien Taiwan R.O.C. 80L[][]YY
MID# TWLCLTAI1662TAI 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
12/11/95
Leader Well Co. Ltd.
Taiwan
Neo Sigma Inc.
Taiwan
* Sincere Medical Industrial Co. Ltd Examination Gloves
Tower Bridge V. 018E 80F[][]MC
Taipei, Taiwan 80L[][]YY
FEI# 1000479670 80L[][]YZ
80L[][]ZA
80L[][]AC
80N[][]PC
10/22/97
Sunny-Mart Merchandise Co., Ltd. Examination Gloves
Second Floor 39-1, An-Ho Road 80F[][]MC
Taipei, Taiwan 80L[][]YY
ID# TWSUNMER391TAI 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
3/25/93
Taiwan Disposable Products
Taiwan
Terng Nan Industrial Corp. Surgeons Gloves
P O Box 53-368 80N[][]PD
Taipai, Taiwan 79K[][]GO
ID# TWTERNAN5336TAI 3/25/93
(NOTE: FIRM MAY ALSO OPERATE AT FOLLOWING ADDRESS)
9f-9, No. 112, Sec. 4, Chung Hsiao East Road
Taipai, Taiwan
ID# TWTERNAN112TAI
Topas Industrial Co
Taiwan
Tse Fong International Co., Ltd. Examination Gloves
341 Jen Al Road, Sec. 4 80F[][]MC
Taipei, Taiwan 80L[][]YY
80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
10/15/92
Unitech Kingdom Enterprises Co.
Taiwan
THAILAND
A.P. Rubber Co. Ltd. Examination Gloves
26/2 Rajyindee Road 80F[][]MC
Hatyai, Songkhla 80L[][]YY
Thailand 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
10/5/92
Dr. Boo Co., Ltd. Examination Gloves
Ste. # 1102-11th Fl., 80F[][]MC
Wall St. Tower Bldg. 80L[][]YY
33/48 Suriwong Rd. 80L[][]YZ
Bangkok 10500, Thailand 80L[][]ZA
FEI# 3307 80L[][]ZC
80N[][]PC
8/4/97
* C. RUBBER CO., LTD. EXAMINATION GLOVES
162/2 MOO 4 80F[][]MC
PETEHKASAME RD. OMNO 1 80L[][]YY
KRATUMBAN, SAMUTSKORN, 80L[][]YZ
THAILAND 80L[][]ZA
FEI# 1000134310 80L[][]ZC
80N[][]PC
5/17/99
MFR.: Examination Gloves
* COVCO Ltd. 80F[][]MC
A.E. House Building 200/3 80L[][]YY
Ramkhamhaeng 4, Ramkhamhaeng Rd. 80L[][]YZ
Suanluang, Bangkok 10250 80L[][]ZA
Thailand 80L[][]ZC
FEI# 1000292298 80N[][]PC
12/15/98
Dah Lee Rubber Industries Ltd. Examination Gloves
5/61 Niphutsongkraw 1 Road, 80F[][]MC
Soi 1 Hatyai 80L[][]YY
Songkhla 90110 80L[][]YZ
Thailand 80L[][]ZA
FEI# 8040989 80L[][]ZC
MID# THDAHLEE561SON 80N[][]PC
4/29/96
Famont Company Ltd. Examination Gloves
1466 Soi Chantratip Sapan 80F[][]MC
2 1/2 Chan Rd. Yannawa 80L[][]YY
MID# THFAMCOM1466BAN 80L[][]YZ
MID# THFAMCO1466YAN 80L[][]ZA
80L[][]ZC
80N[][]PC
8/5/93
* Medtexx Industries Examination Gloves
(Thai)Co., Ltd. 80F[][]MC
200 Mu-4 Tambol Tachang 80L[][]YY
Amphur Bangklam 80L[][]YZ
Hatyai, Songkhla 90110 80L[][]ZA
Thailand 80L[][]ZC
FEI# 3003107955 80N[][]PC
8/5/02
PRODUCT CODE CHANGE
9/6/02
* Phutex Products Co., Ltd. Examination Gloves
1-3-5 Krabi Road, Muang Phuket 80F[][]MC
Phuket, Thailand 83000 80L[][]YY
FEI# 1000333397 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
1/26/98
* Safe Shield Co., Ltd. Examination Gloves
43/2 KM 28, Surat-Takuapa Rd. 80LYY, 80FMC, 80LZC, 80LZA,
Phun Phin, Suratthani 80LYZ, 80NPC
Thailand 4/7/06
FEI# 3003145425
TK Glove Products Co., Ltd Examination Gloves
104 Moo 1 Banlum, Vihandeang, 80F[][]MC
Saraburi, Thailand 80L[][]YY
MID# THTKGLO104SAR 80L[][]YZ
MID# THTKGLO104VIH 80L[][]ZA
80L[][]ZC
80N[][]PC
11/30/93
UNITED KINGDOM
Johnson & Johnson MED Limited Examination Gloves
Coronation Road 80F[][]MC
Ascot, Berkshire 80L[][]YY
U.K. SL5 9EY 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
4/16/93
ATTACHMENT B 8/24/07
*** Note: A Warning Letter has been issued to the following firm(s) citing
adulteration within the meaning of Section 501(h) of the Federal Food, Drug
and Cosmetic Act as documented by recurring violations. Future glove
shipments are subject to refusal of admission pursuant to Section
801(a)(1). Non-violative analyses may not be sufficient to remove the
appearance of a violation for manufacturers/shippers on Attachment B, as
stated under Level 3 Detention.
CHINA (CN)
FIRM PRODUCT/PRODUCT CODE
*** Top Glove (Zhangjiang)Co., Ltd. Patient Examination Gloves
3, Zhangjiagang, Xitang Road 80FMC, 80LZA, 80LYZ, 80LZC,
Xizhang, China 80LYY, 80NPC
FEI# 3003994600 8/24/07
Indonesia
*** PT. Eka Wira Asia Examination Gloves
Jl. Haji Zainal Arifin 128 B-C 80F[][]MC
Medan 20112, Indonesia 80L[][]YY
FEI# 3002512629 80L[][]YZ
80L[][]ZA
80L[][]ZC
80N[][]PC
3/10/99
Correction to FEI #
(Old Corporate Office)
7/25/01
*** PT. Eka Wira Asia (Current Corporate Office)
J1. Prof. HM SH No: 40-40A 7/25/01
Medan 20234 - Indonesia
FEI# 3002343185
*** PT. Eka Wira Asia (Current Manufacturing Facility)
J1. Raya Medan Namorabe Ps. IV 7/25/01
Kabupaten Deli Serdang
Indonesia
FEI# 1000435248
Malaysia
*** DASH MEDICAL GLOVES SDN. BHD. EXAMINATION GLOVES
LOT 16 LENGKONGAN HISHAMUDDIN 80F[][]MC
KAW 20, SELAT KLANG UTARA 80L[][]YY
4200 PELABUHAN KLANG 80L[][]YZ
SELANGOR DARUL ESHAN, MALAYSIA 80L[][]ZA
FEI# 1000359083 80L[][]ZC
80N[][]PC
9/7/99
*** Evergrade Healthcare Products Examination Gloves
Sdn. Bhd. 80F[][]MC
lot 2783. 73/4 Miles, Jalan Bakri 80L[][]YY
84200 Muar Johor 80L[][]YZ
Malaysia 80L[][]ZA
FEI# 1000169589 80L[][]ZC
80N[][]PC
12/21/99
*** Glovesworld Industries Inc. Examination Gloves
(formerly Perusahaan Intan Emas Sdn Bhd) 80F[][]MC
Lot P.T. 153 80L[][]YY
Kawasan Perusahaan Beranang 80L[][]YZ
Darul Ehsan 80L[][]ZA
Selangor, Malaysia 56100 80L[][]ZC
FEI# 3168 80N[][]PC
and 3002618198 8/1/00
(OFFICE)
6TH Floor, Wisma Chinese Chamber
258 Jalan Ampang
50450 Kuala Lumpur, Malaysia
FEI# 3002618198
*** PWA Industries Sdn. Bhd. Examination Gloves
BATU 15 1/2 Sungai Pelong 80F[][]MC
47000 Sungai Bulch 80L[][]YY
Selangor Darul Ehsan, Malaysia 80L[][]YZ
FEI# 3000232672 80L[][]ZA
80L[][]ZC
80N[][]PC
5/7/99
*** S.J. Medical Products Examination Gloves
(M) SDN. BHD. 80F[][]MC
Lot 723 Batu 5 1/2 80L[][]YY
Jalan Kapar 80L[][]YZ
42100 Klang Malaysia 80L[][]ZA
FEI# 1000258938 80L[][]ZC
80N[][]PC
2/25/99
*** Tower Rubber Industries Examination Gloves
SDN BHD (Powdered)
Lot 18, Jalan Lingkaran 80F[][]MC
Sultan Hishamuddin 80L[][]YY
Kawasan Perusahaan Selat 80L[][]YZ
Kelang Utara, 42000 Pelabuhan 80L[][]ZA
Kelang, Selangor Darul Ehsan 80L[][]ZC
Malaysia 80N[][]PC
FEI# 3091 1/5/00
TAIWAN (TW)
*** Hiyi Export Company Examination Gloves
5F-13, No. 1, Lane 126 80F[][]MC
Fu-Hsing S. Road Sec. 1 80L[][]YY
Taipei, Taiwan 80L[][]YZ
FEI# 3001631817 80L[][]ZA
80L[][]ZC
80N[][]PC
4/17/01
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