NITRILE POWDER-FREE PATIENT 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 Nitrile Powder-free Patient Examination Gloves.

Pre-market Notification Details

Device IDK962461
510k NumberK962461
Device Name:NITRILE POWDER-FREE PATIENT 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 Received1996-06-25
Decision Date1996-08-14

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