FDA Registration
Active
🇺🇸 United States
BAY MEDICAL
Reg #: 3015128453
·
FEI: 3015128453
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- BAY MEDICAL
- Registration Number
- 3015128453
- FEI Number
- 3015128453
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 460 Valley Drive
- City
- Brisbane
- State
- CA
- ZIP
- 94005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182241
Owner / Operator
- Firm Name
- Bay Medical
- Operator Number
- 10058737
- Address
- 460 Valley Drive
- City
- Brisbane
- State
- CA
- Postal Code
- 94005
- Country
- US
- Correspondent
- David Dorris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2024-10-15 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2024-10-15 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2024-10-15 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2020-05-18 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2024-10-15 |
Proprietary Names
GripProtect® Precise Nitrile Exam Gloves
GripProtect® BLACK 6 Nitrile exam gloves
GripProtect® Ultra 8 mil Latex exam gloves
GripProtect® Precise BLACK Nitrile exam gloves
GripProtect® Precise BLACK Nitrile exam gloves - 50 Count
GripProtect® Precise BLACK 5 Nitrile exam gloves
GripProtect® Operon Latex exam gloves
GripProtect® High Risk 14 mil Latex exam gloves
GripProtect® Vinyl Exam Gloves
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility