FDA Registration
Active
🇲🇾 Malaysia
TG WORLDWIDE SDN. BHD.
Reg #: 3020521811
·
FEI: 3020521811
·
Expires 2026
Products
7
Proprietary Names
5
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- TG WORLDWIDE SDN. BHD.
- Registration Number
- 3020521811
- FEI Number
- 3020521811
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 16 Persiaran Setia Dagang
- City
- Shah Alam Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K182382
Owner / Operator
- Firm Name
- TG WORLDWIDE SDN. BHD.
- Operator Number
- 10082693
- Address
- 16 Persiaran Setia Dagang
- City
- Shah Alam
- State
- Selangor
- Postal Code
- 40170
- Country
- MY
- Correspondent
- Yong Lin Ng
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2021-12-30 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2021-12-30 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-05-15 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-05-15 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2025-12-17 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2021-09-09 |
| Dam, Rubber | EIE | Class 1 | Dental | No | 2021-12-06 |
Proprietary Names
PATIENT EXAMINATION GLOVE
SURGEON GLOVE
POLYMER PATIENT EXAMINATION GLOVE
Finessis Corium
Finessis Zero
Establishment Types
Export Device to the United States But Perform No Other Operation on Device