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 O&M Halyard, Inc., Huizhou Foryou Medical Devices Co., Ltd. and Ray Co., Ltd..
List of Mask, Surgical devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Mask, Surgical devices (product code FXX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General Hospital FDA review panel. Browse all General Hospital devices →