Clearance Summary
KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS received FDA 510(k) clearance under submission number K110455, sponsored by Kimberly-Clark Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2011-04-29.
- Submission: K110455
- Applicant / Sponsor: Kimberly-Clark Corp.
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2011-04-29
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.