Gmp Medicare Sdn. Bhd. is one of 78 FDA 510(k) medical device manufacturers from Malaysia in the dataset, ranked by real submission volume.
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
Gmp Medicare Sdn. Bhd. has 3 FDA 510(k) cleared medical devices. Based in Klang, MY.
Latest FDA clearance: Apr 2025. Active since 2017. Primary specialty: General Hospital.
Browse the FDA 510(k) cleared devices submitted by Gmp Medicare Sdn. Bhd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Tg Medical USA (Inc) as regulatory consultant.
FDA 510(k) Regulatory Record - Gmp Medicare Sdn. Bhd.
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