POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

Vinyl Patient Examination Glove

HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT

The following data is part of a premarket notification filed by Hebei Shenzichen Plastic & Rubber Products Co., Lt with the FDA for Powdered Vinyl Patient Examination Gloves, Clear (non-colored).

Pre-market Notification Details

Device IDK100964
510k NumberK100964
Device Name:POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
ClassificationVinyl Patient Examination Glove
Applicant HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT 209 BEI SI HUAN ZHONG RD HAI D RM 1606 BLDG 1 JIAN XIANG YUAN Beijing,  CN 100083
ContactChu Xiaoan
CorrespondentChu Xiaoan
HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT 209 BEI SI HUAN ZHONG RD HAI D RM 1606 BLDG 1 JIAN XIANG YUAN Beijing,  CN 100083
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-04-07
Decision Date2010-07-16
Summary:summary

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