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

Polymer Patient Examination Glove

Grand Work Plastic Products Co., Ltd

The following data is part of a premarket notification filed by Grand Work Plastic Products Co., Ltd with the FDA for Sterile Powder Free Nitrile Examination Gloves (blue), Tested For Use With Chemotherapy Drugs.

Pre-market Notification Details

Device IDK220250
510k NumberK220250
Device Name:Sterile Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs
ClassificationPolymer Patient Examination Glove
Applicant Grand Work Plastic Products Co., Ltd Donggao Industrial Zone, Zanhuang Shijiazhuang,  CN 050000
ContactWu Yuli
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 Received2022-01-31
Decision Date2022-05-11

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