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

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

Pre-market Notification Details

Device IDK220249
510k NumberK220249
Device Name:Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
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  
Subsequent Product CodeLZC
Subsequent Product CodeQDO
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-31
Decision Date2022-05-26

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