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., Guangdong Kingfa Sci. & Tech.Co., Ltd. and 3M Company.