Clearance Summary
The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask received FDA 510(k) clearance under submission number K211771, sponsored by The Good 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 2022-08-24.
- Submission: K211771
- Applicant / Sponsor: The Good Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2022-08-24
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.