Examination Gloves-Type A(Latex Gloves)

Latex 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 A(latex Gloves).

Pre-market Notification Details

Device IDK214017
510k NumberK214017
Device Name:Examination Gloves-Type A(Latex Gloves)
ClassificationLatex Patient Examination Glove
Applicant Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd No. 316 National Road, Xinju, Changshan Town Jinxian County Nanchang,  CN 331724
ContactJenny Huang
CorrespondentAlice Huang
Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road Minhang District Shanghai,  CN 201114
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-22
Decision Date2022-07-14

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