Clearance Summary
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) received FDA 510(k) clearance under submission number K222266, sponsored by Jingzhou Haixin Green Cross Medical Products 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 2022-09-26.
- Submission: K222266
- Applicant / Sponsor: Jingzhou Haixin Green Cross Medical Products Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2022-09-26
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.