POWDER FREE VINYL EXAMINATION GLOVE

Vinyl Patient Examination Glove

SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD.

The following data is part of a premarket notification filed by Shanghai Foremost Plastic Industrial Co., Ltd. with the FDA for Powder Free Vinyl Examination Glove.

Pre-market Notification Details

Device IDK032071
510k NumberK032071
Device Name:POWDER FREE VINYL EXAMINATION GLOVE
ClassificationVinyl Patient Examination Glove
Applicant SHANGHAI FOREMOST PLASTIC INDUSTRIAL CO., LTD. 30798 US HWY. 19N Palm Harbor,  FL  34684
ContactWilliam E Harris
CorrespondentN. E. Devine
ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids,  MI  49548
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-07-03
Decision Date2003-10-10
Summary:summary

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