FDA Registration
Active
🇲🇾 Malaysia
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Reg #: 3011200663
·
FEI: 3011200663
·
Expires 2025
Products
3
Proprietary Names
2
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
- K201772
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 |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-08-25 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2020-08-25 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2020-08-25 |
Proprietary Names
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
and Fentanyl Citrate (Blue)
Establishment Types
Manufacture Medical Device