FDA Registration
Active
🇺🇸 United States
GCB MEDICAL LLC
Reg #: 3030419987
·
FEI: 3030419987
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- GCB MEDICAL LLC
- Registration Number
- 3030419987
- FEI Number
- 3030419987
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 25 Depot St
- City
- Duxbury
- State
- MA
- ZIP
- 02332
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222129
Owner / Operator
- Firm Name
- GCB Medical LLC
- Operator Number
- 10090007
- Address
- 25 Depot St
- City
- Duxbury
- State
- MA
- Postal Code
- 02332
- Country
- US
- Correspondent
- Jeff Willink
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-07-01 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-07-01 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-07-01 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-07-01 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198