Disposable Medical Nitrile Examination Gloves

Polymer Patient Examination Glove

Nanjing Universal Medical Equipment Co., Ltd

The following data is part of a premarket notification filed by Nanjing Universal Medical Equipment Co., Ltd with the FDA for Disposable Medical Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK220561
510k NumberK220561
Device Name:Disposable Medical Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Nanjing Universal Medical Equipment Co., Ltd 288 Qinhuai Avenue, Yongyang Street, Lishui District Nanjing,  CN 210000
ContactJerry Gao
CorrespondentJerry Gao
Nanjing Universal Medical Equipment Co., Ltd 288 Qinhuai Avenue, Yongyang Street, Lishui District Nanjing,  CN 210000
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-04-14

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