Careglove Global Sdn. Bhd. FDA Approvals

0 new drug approvals and 5 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
Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)510(k)Apr 1, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Special)	Apr 1, 2025
Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)510(k)May 15, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 15, 2023
Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)510(k)Sep 9, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 9, 2022
Powder Free Chloroprene Examination Glove Coloured (Blue, Green)510(k)Aug 5, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 5, 2022
Powder Free Nitrile Examination Gloves, Blue Chemotest510(k)Jan 9, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 9, 2022