FDA Registration
Active
🇺🇸 United States
Nephron Nitrile
Reg #: 3026363353
·
FEI: 3026363353
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- NEPHRON NITRILE
- Registration Number
- 3026363353
- FEI Number
- 3026363353
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4777 12th Street Extension
- City
- West Columbia
- State
- SC
- ZIP
- 29172
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231349
Owner / Operator
- Firm Name
- Nephron Nitrile, LLC
- Operator Number
- 10087302
- Address
- 4777 12th Street Extension
- City
- West Columbia
- State
- SC
- Postal Code
- 29172
- Country
- US
- Correspondent
- Lou W Kennedy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-07-27 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-07-27 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-07-27 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-07-27 |
Proprietary Names
Nephron Nitrile
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device