Data / Medical devices / Malaysia / GMP Medicare Sdn Bhd
GMP Medicare Sdn Bhd: FDA-registered device maker in Siliau Negeri Sembilan, Malaysia, 1 510(k) clearance
GMP Medicare Sdn Bhd is registered with the FDA (registration 9681247) in Siliau Negeri Sembilan, Malaysia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 24, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681247
- FEI number
- 3000281911
- Address
- Lot 2431, Mukim Port Dickson Sendayan, Siliau Negeri Sembilan, Malaysia, 71100
- Owner or operator
- GMP MEDICARE SDN BHD (9076939)
- Roles
- Manufacturer
- First device listed
- February 26, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2021 | K202003 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim | LZA | Substantially Equivalent | Gmp Medicare Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Fentanyl And Other Opioid Protection Glove
Updated February 24, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.