Clearance Summary
Surgical Masks received FDA 510(k) clearance under submission number K203524, sponsored by Bain Medical Equipment (Guangzhou) 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 2021-02-25.
- Submission: K203524
- Applicant / Sponsor: Bain Medical Equipment (Guangzhou) Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2021-02-25
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.