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Central Medicare Sdn Bhd FDA Approvals

0 new drug approvals and 7 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
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl510(k)Oct 2, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 2, 2023
Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl510(k)Jul 24, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 24, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims510(k)Jul 20, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 20, 2023
Green Non Sterile Powder Free Nitrile Examination Gloves510(k)May 23, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 23, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims510(k)Apr 11, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 11, 2022
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.510(k)Dec 22, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021
Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)510(k)May 7, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 7, 2021

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