Disposable Medical Nitrile Gloves

Polymer Patient Examination Glove

Changzhou Yihua Sanitation Material Co., Ltd

The following data is part of a premarket notification filed by Changzhou Yihua Sanitation Material Co., Ltd with the FDA for Disposable Medical Nitrile Gloves.

Pre-market Notification Details

Device IDK211673
510k NumberK211673
Device Name:Disposable Medical Nitrile Gloves
ClassificationPolymer Patient Examination Glove
Applicant Changzhou Yihua Sanitation Material Co., Ltd Sanhekou Village, Zhenglu Town, Tianning District Changzhou,  CN 213000
ContactDing Jie
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 Received2021-06-01
Decision Date2021-09-01

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