# K192362: Aero Blue Performance Surgical Gowns

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Dec 13, 2019 after 105 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981393 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140539: Aero Blue Performance Surgical Gown, Kimberly-Clark Corporation (2014) Summary page 5.

## Recalls of this device
- Oct 31, 2022 · Class II · Z-0343-2023: Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection

## Indications for use
The Aero Blue Performance Surgical gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liquid Barrier classifications.

Source page: https://510kreport.com/device/K192362
Methodology: https://510kreport.com/methodology