POWDERED VINYL PATIENT EXAMINATION GLOVES

Vinyl Patient Examination Glove

ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.

The following data is part of a premarket notification filed by Zhang Jia Gang Fengyuan Plastic Products Co Ltd. with the FDA for Powdered Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK091662
510k NumberK091662
Device Name:POWDERED VINYL PATIENT EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. RM.1606 BLDG.1, JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD. Beijing,  CN 10083
ContactChu Xiaoan
CorrespondentChu Xiaoan
ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD. RM.1606 BLDG.1, JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD. Beijing,  CN 10083
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-09
Decision Date2009-07-30
Summary:summary

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