POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES

Polymer Patient Examination Glove

SHEN WEI (USA), INC.

The following data is part of a premarket notification filed by Shen Wei (usa), Inc. with the FDA for Powder-free Hypoallergenic Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK972090
510k NumberK972090
Device Name:POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
ClassificationPolymer Patient Examination Glove
Applicant SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City,  CA  94587
ContactBelle L Chou
CorrespondentBelle L Chou
SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City,  CA  94587
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-04
Decision Date1997-11-05

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