POWDERED VINYL PATIENT EXAMINATION GLOVES

Vinyl Patient Examination Glove

ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Zibo Hengde Plastic & Rubber Products Co., Ltd. with the FDA for Powdered Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK070008
510k NumberK070008
Device Name:POWDERED VINYL PATIENT EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. NO. 209 BEI SI HUAN ZHONG ROAD Beijing,  CN 10083
ContactChu Xiaoan
CorrespondentChu Xiaoan
ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. NO. 209 BEI SI HUAN ZHONG ROAD Beijing,  CN 10083
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-03
Decision Date2007-02-08
Summary:summary

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