Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

N-acetylprocainamide Control Materials

Changzhou Universal Medical Equipment Co. Ltd

The following data is part of a premarket notification filed by Changzhou Universal Medical Equipment Co. Ltd with the FDA for Disposable Medical Synthetic Nitrile Examination Gloves (non-sterile).

Pre-market Notification Details

Device IDK211667
510k NumberK211667
Device Name:Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
ClassificationN-acetylprocainamide Control Materials
Applicant Changzhou Universal Medical Equipment Co. Ltd No. 6, Xinxi Road, Xinbei District Changzhou,  CN 213000
ContactJerry Gao
CorrespondentJohnson Liu
CNMED Consultant 31 Archer St Upper Mt Gravatt,  AU 4122
Product CodeLAZ  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-01
Decision Date2021-09-23

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