FDA Registration
Active
🇮🇩 Indonesia
Patient Nitrile Examination Gloves, Powder Free, Non-Sterile
Reg #: 3036774599
·
FEI: 3036774599
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- PT NEWPOINT TECHNOLOGY
- Registration Number
- 3036774599
- FEI Number
- 3036774599
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- J6. Pembangkit, Rengas Pulau, Kec. Medan Marelan,
- City
- Kota Medan Sumatera Utara
- Country
- ID
Regulatory Submissions
- 510(k) Number
- K243441
Owner / Operator
- Firm Name
- PT NewPoint Technology
- Operator Number
- 10092673
- Address
- J6. Pembangkit, Rengas Pulau, Kec. Medan Marelan,
- City
- Kota Medan
- State
- Sumatera Utara
- Postal Code
- 20252
- Country
- ID
- Correspondent
- Aditya Pratama
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-02-04 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-02-04 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-02-04 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-02-04 |
Proprietary Names
Patient Nitrile Examination Gloves, Powder Free, Non-Sterile
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device