FDA Product Code FXX: Mask, Surgical
Under FDA product code FXX, surgical masks are cleared as fluid-resistant barriers worn by healthcare workers in surgical and procedural settings.
Surgical masks provide a physical barrier against droplets and splatter from the wearer's mouth and nose, protecting the sterile field and the patient from contamination. They are classified by fluid resistance and bacterial filtration efficiency.
FXX devices are Class II medical devices, regulated under 21 CFR 878.4040 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Owens & Minor (O&M) Halyard, Inc., Makrite Industries, Inc. and Primed Medical Products, Inc..
FDA 510(k) Cleared Mask, Surgical Devices (Product Code FXX)
About Product Code FXX - Regulatory Context
510(k) Submission Activity
607 total 510(k) submissions under product code FXX since 1976, with 607 receiving FDA clearance (average review time: 155 days).
Submission volume has declined in recent years - 22 submissions in the last 24 months compared to 75 in the prior period.
FDA Review Time
Recent submissions under FXX have taken an average of 209 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.
FXX devices are reviewed by the General Hospital panel. Browse all General Hospital devices →