Gmp Medicare Sdn. Bhd. - FDA 510(k) Cleared Devices
Recent clearances: Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl, Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gmp Medicare Sdn. Bhd. General Hospital ✕
3 devices
Cleared
Apr 23, 2025
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60...
General Hospital
26d
Cleared
Feb 24, 2021
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32...
General Hospital
219d
Cleared
Mar 22, 2017
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential...
General Hospital
145d