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

Patient Examination Glove, Specialty

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

Pre-market Notification Details

Device IDK222449
510k NumberK222449
Device Name:Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
ClassificationPatient Examination Glove, Specialty
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
Product CodeLZC  
Subsequent Product CodeLZA
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-08-15
Decision Date2022-08-27

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