Clearance Summary
Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) received FDA 510(k) clearance under submission number K230395, sponsored by Durio Ppe 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 2023-07-17.
- Submission: K230395
- Applicant / Sponsor: Durio Ppe Sdn Bhd
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2023-07-17
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.