Clearance Summary
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW received FDA 510(k) clearance under submission number K203078, sponsored by Huizhou Tianchang Industrial Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2022-08-19.
- Submission: K203078
- Applicant / Sponsor: Huizhou Tianchang Industrial Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2022-08-19
Classification & Regulation
This clearance is catalogued under FDA product code FXX and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.