FDA Registration
Active
🇲🇾 Malaysia
ANSELL N.P. SDN. BHD.
Reg #: 8043736
·
FEI: 3003221560
·
Expires 2026
Products
5
Proprietary Names
2
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- ANSELL N.P. SDN. BHD.
- Registration Number
- 8043736
- FEI Number
- 3003221560
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT 80, AIR KEROH IND. ESTATE
- City
- MELAKA
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K111139
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 |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2013-04-17 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2013-04-17 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 2020-01-06 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-05-30 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2007-11-29 |
Proprietary Names
GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS
PI Hybrid Micro
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device