K232849

Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

510(k) number: K232849
Device name: Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)
Applicant: Owens & Minor (O&M) Halyard, Inc. VA · US
Product code: FYC — Gown, Isolation, Surgical
Decision date: 2024-05-16
Date received: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Advisory committee: General, Plastic Surgery

510(k) Summary (official FDA PDF): K232849.pdf

Official FDA record: K232849

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.