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).
|Device Name:||Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)|
|Classification||N-acetylprocainamide Control Materials|
|Applicant||Changzhou Universal Medical Equipment Co. Ltd No. 6, Xinxi Road, Xinbei District Changzhou, CN 213000|
CNMED Consultant 31 Archer St Upper Mt Gravatt, AU 4122
|CFR Regulation Number||862.3280 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|