POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5

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 Butadiene Copolymer Exam Gloves With Aloe, Vitamins E Ph5.5.

Pre-market Notification Details

Device IDK011961
510k NumberK011961
Device Name:POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
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 Received2001-06-22
Decision Date2001-09-26

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