Submission Details
| 510(k) Number | K252313 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Cardinal Health Nitrile Examination Gloves Extended Cuff
Jan 2026
Decision
173d
Days
Class 1
Risk
About This 510(k) Submission
K252313 is an FDA 510(k) clearance for the Cardinal Health Nitrile Examination Gloves Extended Cuff, 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 review panel. Regulated under 21 CFR 880.6250.
Device Classification
| 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 Surgeon?s) 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. |
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