Disposable Nitrile Gloves

Polymer Patient Examination Glove

Fujian Ercon Medical Management Co., Ltd.

The following data is part of a premarket notification filed by Fujian Ercon Medical Management Co., Ltd. with the FDA for Disposable Nitrile Gloves.

Pre-market Notification Details

Device IDK210276
510k NumberK210276
Device Name:Disposable Nitrile Gloves
ClassificationPolymer Patient Examination Glove
Applicant Fujian Ercon Medical Management Co., Ltd. Unit 701, Xinyi International Center, No.3911 Huandao East Road, Siming District Xiamen,  CN 361000
ContactLin Ruijin
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-01
Decision Date2021-04-16

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