Clearance Summary
Disposable medical mask received FDA 510(k) clearance under submission number K202137, sponsored by U-Play Products Corporation. 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 2021-03-04.
- Submission: K202137
- Applicant / Sponsor: U-Play Products Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2021-03-04
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.