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

Polymer Patient Examination Glove

Lingshi Hongruida Health Protection Technology Co., Ltd.

The following data is part of a premarket notification filed by Lingshi Hongruida Health Protection 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 IDK223320
510k NumberK223320
Device Name:Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs And Fentanyl Citrate
ClassificationPolymer Patient Examination Glove
Applicant Lingshi Hongruida Health Protection Technology Co., Ltd. Yangjiayuan, Liangdu Town, Lingshi County Jinzhong,  CN 031300
ContactYin Hongmei
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 Received2022-10-28
Decision Date2022-11-02

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