FDA Registration
Active
🇺🇸 United States
Slate
Reg #: 3024755882
·
FEI: 3024755882
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- AMERICAN NITRILE OPERATIONS LLC
- Registration Number
- 3024755882
- FEI Number
- 3024755882
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3500 Southwest Blvd
- City
- Grove City
- State
- OH
- ZIP
- 43123
- Country
- US
Regulatory Submissions
- 510(k) Number
- K220825
Owner / Operator
- Firm Name
- American Nitrile Operations LLC
- Operator Number
- 10086326
- Address
- 3500 Southwest Blvd
- City
- Grove City
- State
- OH
- Postal Code
- 43123
- Country
- US
- Correspondent
- Tracy Calkins
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2022-10-31 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-10-31 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2022-10-31 |
Proprietary Names
Slate
SteelFlex
Establishment Types
Manufacture Medical Device