Examination Gloves -Type C (Nitrile Gloves)

Polymer Patient Examination Glove

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd

The following data is part of a premarket notification filed by Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd with the FDA for Examination Gloves -type C (nitrile Gloves).

Pre-market Notification Details

Device IDK212290
510k NumberK212290
Device Name:Examination Gloves -Type C (Nitrile Gloves)
ClassificationPolymer Patient Examination Glove
Applicant Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd 316 National Road, Xinju, Changshan Town, Jinxian County Nanchang,  CN 331724
ContactJenny Huang
CorrespondentEvan Hu
Shanghai Mind-link Consulting Co., Ltd. 639 Jiaozhou Road Shanghai,  CN 200040
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-21
Decision Date2021-10-28

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