Disposable Sterilized Latex Surgical Gloves

Surgeon's Gloves

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 Disposable Sterilized Latex Surgical Gloves.

Pre-market Notification Details

Device IDK211953
510k NumberK211953
Device Name:Disposable Sterilized Latex Surgical Gloves
ClassificationSurgeon's Gloves
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 A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai,  CN 200040
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-23
Decision Date2022-05-25

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