Clearance Summary
Surgical Face Masks (Ear Loops And Tie-On) received FDA 510(k) clearance under submission number K221534, sponsored by San-M Package 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 2022-09-16.
- Submission: K221534
- Applicant / Sponsor: San-M Package Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2022-09-16
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.