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)

510(k) number: K253003
Device name: 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. CN
Product code: FYA — Gown, Surgical
Decision date: 2026-04-20
Date received: 2025-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain

Also available from FDA: K253003.pdf

Official FDA record: K253003

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.