PREPOWDERED VINYL EXAM GLOVES

Vinyl Patient Examination Glove

DYNAREX CORP.

The following data is part of a premarket notification filed by Dynarex Corp. with the FDA for Prepowdered Vinyl Exam Gloves.

Pre-market Notification Details

Device IDK893334
510k NumberK893334
Device Name:PREPOWDERED VINYL EXAM GLOVES
ClassificationVinyl Patient Examination Glove
Applicant DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster,  NY  10509
ContactMarvin D Schattner
CorrespondentMarvin D Schattner
DYNAREX CORP. ONE INTERNATIONAL BLVD. Brewster,  NY  10509
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-20
Decision Date1989-08-15

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