POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)

Vinyl Patient Examination Glove

TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD

The following data is part of a premarket notification filed by Tangshan Hengda Plastic Products Co., Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Colored (yellow).

Pre-market Notification Details

Device IDK102559
510k NumberK102559
Device Name:POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
ClassificationVinyl Patient Examination Glove
Applicant TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD #209 BEI SI HUAN ZHONG ROAD RM 1606 BLDG 1 JIANXIANG YUAN Haidian District, Beijing,  CN 100083
ContactChu Xiaoan
CorrespondentChu Xiaoan
TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD #209 BEI SI HUAN ZHONG ROAD RM 1606 BLDG 1 JIANXIANG YUAN Haidian District, Beijing,  CN 100083
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-07
Decision Date2010-10-21
Summary:summary

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