FDA Registration
Active
🇺🇸 United States
medava® SoftTouch Nitrile Powder Free Examination Gloves Tested for Use w/ Chemotherapy Drugs and Fentanyl, (Blue)
Reg #: 3015727296
·
FEI: 3015727296
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- UNITE MEDICAL, LLC
- Registration Number
- 3015727296
- FEI Number
- 3015727296
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1487 Trae Lane
- City
- Lithia Springs
- State
- GA
- ZIP
- 30122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200019
Owner / Operator
- Firm Name
- Unite Medical, LLC
- Operator Number
- 10061044
- Address
- 1487 Trae Lane
- City
- Lithia Springs
- State
- GA
- Postal Code
- 30122
- Country
- US
- Correspondent
- Richard Reed
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-03-10 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-03-10 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-03-10 |
Proprietary Names
medava® SoftTouch Nitrile Powder Free Examination Gloves Tested for Use w/ Chemotherapy Drugs and Fentanyl, (Blue)
Establishment Types
Complaint File Establishment per 21 CFR 820.198