FDA Registration
Active
🇲🇾 Malaysia
Polymer Patient Examination Glove
Reg #: 9681247
·
FEI: 3000281911
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- GMP MEDICARE SDN BHD
- Registration Number
- 9681247
- FEI Number
- 3000281911
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 2431, Mukim Port Dickson, Sendayan
- City
- Siliau Negeri Sembilan
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K222129
Owner / Operator
- Firm Name
- GMP MEDICARE SDN BHD
- Operator Number
- 9076939
- Address
- Lot/PT 64593, Jalan Dahlia/KU8,, Kawasan Perindustrian Meru Timur
- City
- Klang
- State
- Selangor
- Postal Code
- 41050
- Country
- MY
- Correspondent
- Bong Khoon Seng
US Agent
- Business Name
- TG MEDICAL (USA), INC.
- Contact Name
- David Lim
- Address
- 155 N. Aspan Ave
- City
- Azusa
- State
- CA
- ZIP
- 91702
- Country
- US
- [email protected]
- Phone
- 626 9697838 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-12-02 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-12-02 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-12-02 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-12-02 |
Proprietary Names
Polymer Patient Examination Glove
Establishment Types
Manufacture Medical Device