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, Yadu Medical (Henan) Co., Ltd. and Nanning Tecbod Biological Technology Co., Ltd..
FDA 510(k) Cleared Gown, Surgical Devices (Product Code FYA)
About Product Code FYA - Regulatory Context
510(k) Submission Activity
293 total 510(k) submissions under product code FYA since 1976, with 293 receiving FDA clearance (average review time: 165 days).
Submission volume has declined in recent years - 11 submissions in the last 24 months compared to 27 in the prior period.
FDA Review Time
Recent submissions under FYA have taken an average of 209 days to reach a decision - up from 163 days historically. Manufacturers should account for longer review timelines in current project planning.
FYA devices are reviewed by the General Hospital panel. Browse all General Hospital devices →