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

Polymer Patient Examination Glove

Better Care Plastic Technology Co., Ltd.

The following data is part of a premarket notification filed by Better Care Plastic Technology Co., Ltd. with the FDA for Powder Free Nitrile Examination Gloves (blue),tested For Use With Chemotherapy Drugs And Fentanyl Citrate.

Pre-market Notification Details

Device IDK221269
510k NumberK221269
Device Name:Powder Free Nitrile Examination Gloves (Blue),Tested For Use With Chemotherapy Drugs And Fentanyl Citrate
ClassificationPolymer Patient Examination Glove
Applicant Better Care Plastic Technology Co., Ltd. Fuqian Xi Road, West District Of Shenze Industrial Base Shenze County,  CN 050000
ContactZhu Chunyan
CorrespondentKathy Liu
Hongray USA Medical Products Inc. 3973 Schaefer Avenue, Chino, CA 91710, USA Chino,  CA  91710
Product CodeLZA  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-07-27

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