FDA Registration
Active
🇺🇸 United States
Black Talon Gloves
Reg #: 3005034064
·
FEI: 3005034064
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- NORTH AMERICAN RESCUE, LLC.
- Registration Number
- 3005034064
- FEI Number
- 3005034064
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 35 TEDWALL COURT
- City
- Greer
- State
- SC
- ZIP
- 29650
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232654
Owner / Operator
- Firm Name
- NORTH AMERICAN RESCUE, LLC.
- Operator Number
- 9070484
- Address
- 35 TEDWALL COURT, --
- City
- Greer
- State
- SC
- Postal Code
- 29650
- Country
- US
- Correspondent
- Savanah Sitton
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-12-11 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2024-12-11 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-12-11 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-12-11 |
Proprietary Names
Black Talon Gloves
Establishment Types
Repack or Relabel Medical Device