K252301
- 510(k) number
- K252301
- Device name
- Henan Yadu Level 4 Surgical Gowns (Reinforced)
- Applicant
- Yadu Medical (Henan) Co., Ltd. CN
- Product code
- FYA — Gown, Surgical
- Decision date
- 2026-02-04
- Date received
- 2025-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252301.pdf
Official FDA record: K252301
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.