FDA Registration
Active
🇲🇾 Malaysia
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
Reg #: 3005568780
·
FEI: 3003116055
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
- Registration Number
- 3005568780
- FEI Number
- 3003116055
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOT 821, JALAN MATANG, MATANG
- City
- TAIPING Perak
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K032444
Owner / Operator
- Firm Name
- COMFORT RUBBER GLOVES INDUSTRIES SDN BHD
- Operator Number
- 9008127
- Address
- LOT 821, JALAN MATANG, MATANG, --
- City
- TAIPING, PERAK
- State
- MY-NOTA
- Postal Code
- 34750
- Country
- MY
- Correspondent
- LEONG - HON WENG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2017-11-29 |
Proprietary Names
NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)