FDA Registration
Active
🇺🇸 United States
Nitrile Powder Free Examination Gloves
Reg #: 3003895865
·
FEI: 3003895865
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HI-DOW INTERNATIONAL INC.
- Registration Number
- 3003895865
- FEI Number
- 3003895865
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2555 Metro Blvd
- City
- Maryland Heights
- State
- MO
- ZIP
- 63043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071910
Owner / Operator
- Firm Name
- Hi-Dow International Incorporated
- Operator Number
- 9052765
- Address
- 2555 Metro Blvd, --
- City
- Maryland Heights
- State
- MO
- Postal Code
- 63043
- Country
- US
- Correspondent
- Eric Y Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-06-30 |
Proprietary Names
Nitrile Powder Free Examination Gloves
Establishment Types
Complaint File Establishment per 21 CFR 820.198