POWDER-FREE LATEX EXAMINATION GLOVES

Latex 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 Latex Examination Gloves.

Pre-market Notification Details

Device IDK935812
510k NumberK935812
Device Name:POWDER-FREE LATEX EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant SHEN WEI (USA), INC. 1163 CHESS DRIVE, SUITE D Foster City,  CA  94404
ContactWillis L.u. Chou
CorrespondentWillis L.u. Chou
SHEN WEI (USA), INC. 1163 CHESS DRIVE, SUITE D Foster City,  CA  94404
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-02
Decision Date1994-03-23

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