Disposable Nitrile Gloves

Polymer Patient Examination Glove

Jiangsu Jinke Protective Equipment Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Jinke Protective Equipment Co., Ltd with the FDA for Disposable Nitrile Gloves.

Pre-market Notification Details

Device IDK211781
510k NumberK211781
Device Name:Disposable Nitrile Gloves
ClassificationPolymer Patient Examination Glove
Applicant Jiangsu Jinke Protective Equipment Co., Ltd West Shuangyang Road(South Side), Sihong Economic Development Zone Suqian,  CN 223900
ContactMia Lai
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room608, No.738, Shangcheng Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-09
Decision Date2021-09-29

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