Hunan Zhenheyikang Medical Instrument Co., Ltd. FDA Approvals

0 new drug approvals and 2 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
Medical Nitrile Examination Gloves510(k)Apr 3, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 3, 2022
Medical Surgical Mask510(k)Feb 20, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 20, 2022