DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES

Surgeon's Gloves

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Dextren(tm) Powder Free Hypoallergenic Gloves.

Pre-market Notification Details

Device IDK935869
510k NumberK935869
Device Name:DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES
ClassificationSurgeon's Gloves
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactMarcia C Leatham
CorrespondentMarcia C Leatham
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-03
Decision Date1994-02-24

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