FDA Registration
Active
🇲🇾 Malaysia
Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Reg #: 9613998
·
FEI: 3006581410
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GALLANT QUALITY SDN. BHD.
- Registration Number
- 9613998
- FEI Number
- 3006581410
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOT 1874, JALAN KAMPUNG DEW
- City
- TAIPING, PERAK
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K192954
Owner / Operator
- Firm Name
- GALLANT QUALITY SDN BHD
- Operator Number
- 9103901
- Address
- LOT 1874, JALAN KAMPUNG DEW, --
- City
- TAIPING, PERAK
- State
- MY-NOTA
- Postal Code
- 34700
- Country
- MY
- Correspondent
- Leong - Wai Leong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-01-11 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2022-01-11 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-01-11 |
Proprietary Names
Blue Colored, Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)