DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR

Vinyl 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 Disposal Powder Free Vinyl Synthetic Examination Gloves, Green Color.

Pre-market Notification Details

Device IDK033539
510k NumberK033539
Device Name:DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
ClassificationVinyl Patient Examination Glove
Applicant SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City,  CA  94587
ContactCynthia Liu
CorrespondentCynthia Liu
SHEN WEI (USA), INC. 2845 WHIPPLE RD. Union City,  CA  94587
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-10
Decision Date2004-01-08

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