Jiangxi Kemei Medical Apparatus & Instruments Group 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
Examination gloves-Type A(Latex gloves)510(k)Jul 14, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 14, 2022
Disposable Sterilized Latex Surgical Gloves510(k)May 25, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 25, 2022
Examination gloves -Type C (Nitrile gloves)510(k)Oct 28, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 28, 2021