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Adverse Event Report

ALLEGIANCE HEALTHCARE CORP GLOVE,EXAM,MEDIUM,POWDERFREE EXAM GLOVE   back to search results
Model Number 8877
Event Date 04/01/1998
Event Type  Other   Patient Outcome  Other;
Manufacturer Narrative

A small percentage of the population may experience sensitization reaction to some of the materials in the latex gloves. Rate of sensitivity increase for those with a high degree of exposure to latex, such as healthcare workers. Some individuals experience reactions to antioxidants & accelerators which are added into the latex in the mfg process. Other individuals react to the protein present in the latex itself.

 
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Brand NameGLOVE,EXAM,MEDIUM,POWDERFREE
Type of DeviceEXAM GLOVE
Baseline Brand NamePOSITIVE TOUCH PF LATEX EXAM GLOVES
Baseline Generic NamePF LATEX EXAM GLOVES
Baseline Catalogue Number8877
Baseline Model Number8877
Baseline Device FamilyPF LATEX EXAM GLOVES
Baseline Device 510(K) NumberK012149
Baseline Device PMA Number
Baseline Shelf Life Information No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed09/24/2001
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE CORP
1500 waukegan road
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE CORP
1500 waukegan road
mcgaw park IL 60085
Manufacturer Contact
patricia sharpe-gregg
1500 waukegan rd
mcgaw park , IL 60085
(847) 578 -3636
Device Event Key288997
MDR Report Key310142
Event Key280444
Report Number1423507-2000-00338
Device Sequence Number1
Product CodeLYY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/28/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2000
Is This An Adverse Event Report? No
Device Operator Health Professional
Device MODEL Number8877
Device Catalogue Number8877
Was Device Available For Evaluation? No
Date Manufacturer Received12/04/2000
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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