K253243
- 510(k) number
- K253243
- Device name
- Cardinal Health Poly Reinforced Surgical Gown
- Applicant
- Cardinal Health 200, LLC IL · US
- Product code
- FYA — Gown, Surgical
- Decision date
- 2026-04-28
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K253243
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.