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) 号: K253003
器械名称: 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)
申请人: Hubei Xinxin Non-Woven Co., Ltd. CN
产品代码: FYA — Gown, Surgical
批准日期: 2026-04-20
受理日期: 2025-09-19
决定: Substantially Equivalent
审查途径: Traditional
咨询委员会: General, Plastic Surgery

PDF下载 510(k) Summary本站存档 · 2.9 MB · FDA 公有领域文件

也可从 FDA 官方下载： K253003.pdf

FDA 官方记录： K253003

数据来自 openFDA 510(k) 数据集（CC0 公有领域），以 FDA 现行记录为准。510(k) 许可不等于 FDA 认证或批准。