FDA Product Code FYA: Gown, Surgical
FDA product code FYA covers surgical gowns worn by members of the surgical team during operative procedures.
These disposable or reusable gowns provide a sterile barrier that protects both the patient from microbial contamination and the healthcare worker from exposure to blood and body fluids. They are classified by barrier performance level — from minimal to highest protection — based on the expected fluid exposure.
FYA devices are Class II medical devices, regulated under 21 CFR 878.4040 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Medline Industries, LP, Cardinal Health200, LLC and Standard Textile Co., Inc..
List of Gown, Surgical devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Gown, Surgical devices (product code FYA). 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 →