K261028
- 510(k) number
- K261028
- Device name
- Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- Applicant
- Yadu Medical (Henan) Co., Ltd. CN
- Product code
- FYA — Gown, Surgical
- Decision date
- 2026-08-07
- Date received
- 2026-03-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K261028.pdf
Official FDA record: K261028
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.