POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

Vinyl Patient Examination Glove

HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD.

The following data is part of a premarket notification filed by Hebei Hongtai Plastic Products Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.

Pre-market Notification Details

Device IDK102817
510k NumberK102817
Device Name:POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ClassificationVinyl Patient Examination Glove
Applicant HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. ROOM 3-402, NO 71 MAJIAPU YANGQIAO, FENGTAI DIST Beijing,  CN 100068
ContactRichard Lu
CorrespondentRichard Lu
HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. ROOM 3-402, NO 71 MAJIAPU YANGQIAO, FENGTAI DIST Beijing,  CN 100068
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-28
Decision Date2010-12-23
Summary:summary

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