FDA Registration
Active
🇺🇸 United States
KIMTECH Polaris Nitrile Powder-Free Exam Gloves
Reg #: 1033422
·
FEI: 1000015879
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- KIMBERLY-CLARK CORPORATION
- Registration Number
- 1033422
- FEI Number
- 1000015879
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1400 Holcomb Bridge Rd
- City
- Roswell
- State
- GA
- ZIP
- 30076
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231021
Owner / Operator
- Firm Name
- KIMBERLY-CLARK CORPORATION
- Operator Number
- 9001775
- Address
- 1400 Holcomb Bridge Road, --
- City
- Roswell
- State
- GA
- Postal Code
- 30076
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-09-11 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-09-11 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-09-11 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-09-11 |
Proprietary Names
KIMTECH Polaris Nitrile Powder-Free Exam Gloves
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility