Disposable Nitrile Examination Gloves

Polymer Patient Examination Glove

Fujian Yuanxin Safety Protection Technology Co., Ltd.

The following data is part of a premarket notification filed by Fujian Yuanxin Safety Protection Technology Co., Ltd. with the FDA for Disposable Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK212485
510k NumberK212485
Device Name:Disposable Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Fujian Yuanxin Safety Protection Technology Co., Ltd. Xiacun Medical Industry Zone, Zherong County Ningde,  CN 355300
ContactAlan Wu
CorrespondentBoyle Wang
Shanghai Truthful Information Technology Co., Ltd. Room608,No.738,Shangcheng Rd.,Pudong Shanghai,  CN 200120
Product CodeLZA  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-09
Decision Date2021-11-05

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