K252313 is an FDA 510(k) clearance for the Cardinal Health Nitrile Examination Gloves Extended Cuff. This device is classified as a Medical Glove, Specialty (Class I - General Controls, product code LZC).
Submitted by Cardinalhealth (Waukegan, US). The FDA issued a Cleared decision on January 14, 2026, 173 days after receiving the submission on July 25, 2025.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Disposable Medical Glove (examination Or Surgeons) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc..
| 510(k) Number | K252313 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2025 |
| Decision Date | January 14, 2026 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LZC — Medical Glove, Specialty |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Disposable Medical Glove (examination Or Surgeons) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc. |