Nitrile Examination Gloves

Polymer Patient Examination Glove

Anhui Fine Glove Medical Technology Co., Ltd

The following data is part of a premarket notification filed by Anhui Fine Glove Medical Technology Co., Ltd with the FDA for Nitrile Examination Gloves.

Pre-market Notification Details

Device IDK212551
510k NumberK212551
Device Name:Nitrile Examination Gloves
ClassificationPolymer Patient Examination Glove
Applicant Anhui Fine Glove Medical Technology Co., Ltd Intersection Of Feng Xiang Avenue And GongYe Road Chuzhou,  CN 233100
ContactGuanghao Liu
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 Received2021-08-13
Decision Date2021-11-05

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.