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 Standard Textile Co., Inc., Medline Industries, Inc. and Kimberly-Clark Corp..