Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs

Polymer 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 Nitrile Examination Gloves (blue), Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK211604
510k NumberK211604
Device Name:Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County Lifen,  CN 042300
ContactWu Zhigang
CorrespondentKathy Liu
Hongray USA Medical Products Inc. 3973 Schaefer Avenue Chino,  CA  91710
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-25
Decision Date2021-10-27

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