Clearance Summary
AAMI4 Isolation Gown received FDA 510(k) clearance under submission number K214116, 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 2022-10-11.
- Submission: K214116
- 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: 2022-10-11
Classification & Regulation
This clearance is catalogued under FDA product code FYC and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.