Changzhou Universal Medical Equipment Co., Ltd. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs510(k)Mar 10, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 10, 2022
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)510(k)Sep 23, 2021Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Sep 23, 2021
Nitrile Glove Powder Free Blue510(k)Apr 21, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 21, 2021