Clearance Summary
R&G Surgical Mask received FDA 510(k) clearance under submission number K232112, sponsored by R&G Seguridad E Higiene Industrial S.A.C.. 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 2024-04-02.
- Submission: K232112
- Applicant / Sponsor: R&G Seguridad E Higiene Industrial S.A.C.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2024-04-02
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.