FDA Registration
Active
🇺🇸 United States
Medline Green Ambidextrous PF Nitrile Exam Gloves With Colloidal Oatmeal USP (Tested For Use With Chemotherapy Drugs)
Reg #: 1417592
·
FEI: 1417592
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- MEDLINE INDUSTRIES, LP - Northfield
- Registration Number
- 1417592
- FEI Number
- 1417592
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- Three Lakes Drive
- City
- Northfield
- State
- IL
- ZIP
- 60093
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192315
Owner / Operator
- Firm Name
- Medline Industries, LP
- Operator Number
- 1417592
- Address
- Three Lakes Drive
- City
- Northfield
- State
- IL
- Postal Code
- 60093
- Country
- US
- Correspondent
- Stephanie Augsburg
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2020-07-30 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-07-30 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2020-07-30 |
Proprietary Names
Medline Green Ambidextrous PF Nitrile Exam Gloves With Colloidal Oatmeal USP (Tested For Use With Chemotherapy Drugs)
Medline Restore Touch Nitrile Exam Gloves with Oatmeal
Medline Restore Sense Powder Free Nitrile Exam Gloves with maxOat+
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility