Clearance Summary
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) received FDA 510(k) clearance under submission number K253003, sponsored by Hubei Xinxin Non-Woven Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-04-20.
- Submission: K253003
- Applicant / Sponsor: Hubei Xinxin Non-Woven Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2026-04-20
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.