Clearance Summary
Cross Protection ResQ300 Plus Surgical Face Mask received FDA 510(k) clearance under submission number K212273, sponsored by Cross Protection (M) Sdn Bhd. 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 2022-08-17.
- Submission: K212273
- Applicant / Sponsor: Cross Protection (M) Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2022-08-17
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.