Disposable Medical Nitrile Examination Gloves (Non-sterile)

Polymer Patient Examination Glove

Suqian Linglian Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Suqian Linglian Medical Technology Co., Ltd with the FDA for Disposable Medical Nitrile Examination Gloves (non-sterile).

Pre-market Notification Details

Device IDK212600
510k NumberK212600
Device Name:Disposable Medical Nitrile Examination Gloves (Non-sterile)
ClassificationPolymer Patient Examination Glove
Applicant Suqian Linglian Medical Technology Co., Ltd No 1 Rd Wanpi Industrial Park, Xinshuguan Road, Shuyang County Suqian,  CN 223699
ContactEric Li
CorrespondentJohnson Liu
CNMED Consultant 31 Archer St Upper Mt Gravatt,  AU 4122
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-17
Decision Date2021-11-18

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