Non-sterile Level 3 Surgical Gown (4025) +3 more— 510(k) K253003
Substantially EquivalentHubei Xinxin Non-Woven Co., Ltd.
FDA 510(k) clearance K253003 for Non-sterile Level 3 Surgical Gown (4025) +3 more, Substantially Equivalent on 2026-04-20. Applicant: Hubei Xinxin Non-Woven Co., Ltd.. Device class: 2.
Summary
Hubei Xinxin Non-Woven's record names four surgical gowns: Non-sterile Level 3 (4025), Sterile Level 3 (M4025), Non-sterile Reinforced Level 4 (G4025), and Reinforced Sterile Level 4 (GM4025). All four are filed under product code FYA (Gown, Surgical).
Class II, 21 CFR 878.4040. The General Hospital review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Hubei Xinxin Non-Woven filed from Xiantao, China. The decision came 213 calendar days after FDA received it (September 19, 2025 to April 20, 2026).
Clearance details
- Device name as filed
- 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)
- Applicant
- Hubei Xinxin Non-Woven Co., Ltd.
- Product code
- Product 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
- Xiantao, CN
Recent devices under product code FYA
view all- K260407 — Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns (Reinforced) and Principle & Will ANSI/AMMI PB70 (Sterile/Non-sterile) Level 4 Surgical Gowns/Isolation Gowns
- K261028 — Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
- 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)
More clearances from Hubei Xinxin Non-Woven Co., Ltd.
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