FDA Registration
Active
🇲🇾 Malaysia
Chlorinated PF Latex Exam Glove with Protein Labeling Claim 50ug or less
Reg #: 3011200663
·
FEI: 3011200663
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
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
- K991616
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 |
|---|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2017-05-19 |
Proprietary Names
Chlorinated PF Latex Exam Glove with Protein Labeling Claim 50ug or less
Labsco Latex Powder Free
Quala Latex Powder Free
Pro advantage Latex Powder Free
Establishment Types
Manufacture Medical Device