FYC

Gown, Isolation, Surgical

Product code: FYC
Device name: Gown, Isolation, Surgical
Device class: Class 2
21 CFR: 21 CFR 878.4040
Medical specialty: General, Plastic Surgery
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 2
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 68 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-05-16.

Number	Decision date	Applicant	Device name	Summary
K232849	2024-05-16	Owens & Minor (O&M) Halyard, Inc.	Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54	FDA
K230135	2023-10-04	Copioumed International, Inc.	Copioumed Chemotherapy Isolation Gown	PDF

1 summaries are archived here for direct download.

Official FDA classification page: FYC

Classification and pathway per current FDA publications. Data from openFDA (CC0).