FDA Registration
Active
🇲🇾 Malaysia
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue)
Reg #: 3019769825
·
FEI: 3019769825
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- HARTALEGA NGC SDN. BHD. (LOT 39496)
- Registration Number
- 3019769825
- FEI Number
- 3019769825
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,
- City
- Sepang Selangor
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K190454
Owner / Operator
- Firm Name
- Hartalega NGC Sdn. Bhd. (Lot 39496)
- Operator Number
- 10090827
- Address
- No.2 (Lot 39496), Persiaran Tanjung, Kawasan Perindustrian Tanjung, Jalan B20,
- City
- Sepang
- State
- Selangor
- Postal Code
- 43900
- Country
- MY
- Correspondent
- Eu Jin Kuan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-10-30 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-10-30 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-10-30 |
Proprietary Names
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)