Powder Free Vinyl Patient Examination Gloves (Yellow, White)

Vinyl Patient Examination Glove

Shanxi Hongjin Plastic Technology Co., Ltd

The following data is part of a premarket notification filed by Shanxi Hongjin Plastic Technology Co., Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves (yellow, White).

Pre-market Notification Details

Device IDK180260
510k NumberK180260
Device Name:Powder Free Vinyl Patient Examination Gloves (Yellow, White)
ClassificationVinyl Patient Examination Glove
Applicant Shanxi Hongjin Plastic Technology Co., Ltd Coal Bed Gas Industrial Zone, Qu'e Town, Daning County Linfen City,  CN 042399
ContactWu Zhigang
CorrespondentKathy Liu
Hongray USA Medical Products Inc 3973 Schaefer Ave. Chino,  CA  91710
Product CodeLYZ  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-30
Decision Date2018-06-12
Summary:summary

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