FDA Registration
Active
🇲🇾 Malaysia
GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Reg #: 8043736
·
FEI: 3003221560
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ANSELL N.P. SDN. BHD.
- Registration Number
- 8043736
- FEI Number
- 3003221560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LOT 80, AIR KEROH IND. ESTATE
- City
- MELAKA
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K213289
Owner / Operator
- Firm Name
- ANSELL HEALTHCARE PRODUCTS LLC
- Operator Number
- 8020065
- Address
- 2301 Robb Drive
- City
- Reno
- State
- NV
- Postal Code
- 89523
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-05-30 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-05-30 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2023-05-30 |
Proprietary Names
GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Establishment Types
Manufacture Medical Device