K252313
- 510(k) number
- K252313
- Device name
- Cardinal Health Nitrile Examination Gloves Extended Cuff
- Applicant
- Cardinalhealth IL · US
- Product code
- LZC — Medical Glove, Specialty
- Decision date
- 2026-01-14
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K252313
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.