Eco Medi Glove 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
Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid510(k)Feb 26, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 26, 2024
Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate510(k)Feb 7, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 7, 2024
Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim510(k)Dec 28, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 28, 2023
Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim510(k)Jul 19, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 19, 2022
Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein510(k)Feb 17, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 17, 2021