Nitrile Examination Glove (Powder Free, Blue)

Polymer Patient Examination Glove

Jiangsu Jinlian Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Jinlian Medical Technology Co., Ltd with the FDA for Nitrile Examination Glove (powder Free, Blue).

Pre-market Notification Details

Device IDK212497
510k NumberK212497
Device Name:Nitrile Examination Glove (Powder Free, Blue)
ClassificationPolymer Patient Examination Glove
Applicant Jiangsu Jinlian Medical Technology Co., Ltd No. 14 Factory Building, 1st Floor West Of Century Aveneul, Suqian Econo-Tech-Deve-Zone Suqian,  CN 223800
ContactWu Min
CorrespondentRay Wang
Beijin Believe-Med Technology Service Co., Ltd Rm.912, Building#15, XiYueHui, No.5, YiHe North Rd. FangShan District Beigin,  CN 102401
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-11-11

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