Clearance Summary
Medical Surgical Mask (Planar type) received FDA 510(k) clearance under submission number K220824, sponsored by Hunan Chopard Medical Devices 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 2022-05-19.
- Submission: K220824
- Applicant / Sponsor: Hunan Chopard Medical Devices Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2022-05-19
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.