Edma Group, LLC 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
Edma Synthetic Nitrile Examination Gloves510(k)Aug 9, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 9, 2021
Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)510(k)Jul 15, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 15, 2021