FDA Registration
Active
🇲🇾 Malaysia
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black)
Reg #: 3011200663
·
FEI: 3011200663
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- HARTALEGA NGC SDN BHD
- Registration Number
- 3011200663
- FEI Number
- 3011200663
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
- City
- Sepang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K200019
Owner / Operator
- Firm Name
- HARTALEGA NGC SDN BHD
- Operator Number
- 10047371
- Address
- No. 1, Persiaran Tanjung, Kawasan Perindustrian Tanjung
- City
- Sepang
- State
- Selangor
- Postal Code
- 43900
- Country
- MY
- Correspondent
- KUAN MUN LEONG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2020-04-07 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-04-07 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2020-04-07 |
Proprietary Names
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Black)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drug and Fentanyl Citrate (Blue)
CRITERION N300 BLACK
Establishment Types
Manufacture Medical Device