New Era Medicare Sdn. Bhd. 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
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)510(k)Aug 16, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 16, 2023
Sterile Surgical Powder Free Latex Glove510(k)Jan 26, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 26, 2023
Non Sterile Powder Free Latex Examination Glove510(k)Oct 28, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 28, 2022