Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)— 510(k) K261028
Substantially EquivalentYadu Medical (Henan) Co., Ltd.
FDA 510(k) clearance K261028 for Surgical Gown Level2 (S, M, L, XL, XXL, XXXL), Substantially Equivalent on 2026-08-07. Applicant: Yadu Medical (Henan) Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Yadu Medical (Henan) Co., Ltd.
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- He Nan, CN
Recent devices under product code FYA
view all- K261949 — NYES Tuff Cuff L3 Disposable Gowns
- K252575 — Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
- K260725 — BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
- K253243 — Cardinal Health Poly Reinforced Surgical Gown
- K253003 — Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
More clearances from Yadu Medical (Henan) Co., Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.