# K232849: Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)

- Pathway: 510(k) (Abbreviated)
- Applicant: Owens & Minor (O&M) Halyard, Inc.
- Decided: May 16, 2024 after 245 days
- Product code: FYC (Gown, Isolation, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981393 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160361: PRIMAGARD Isolation Gown (AAMI PB70 Level 3), Primed Medical Products, Inc. (2016) Summary page 5.

## Indications for use
Halyard Tri-Layer AAMI 3 Isolation Gowns are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for healthcare personnel and patients from microorganism transfer, body fluids, and particulate matter. The gowns are non-sterile, single use, and meet AAMI PB70:2012 level 3 Liquid Barrier performance requirements. Not intended for use in the operating room.

Source page: https://510kreport.com/device/K232849
Methodology: https://510kreport.com/methodology