# K210688: AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown

- Pathway: 510(k) (Abbreviated)
- Applicant: O&M Halyard, Inc.
- Decided: Jul 21, 2021 after 135 days
- Product code: FYA (Gown, 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: 6 generations back to K981393 (1998). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200522: AERO CHROME* Breathable Performance Surgical Gowns, O&M Halyard, Inc. (2020) Summary page 5.

## Indications for use
The AERO CHROME* Select Breathable 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 micro-organisms, body fluids, and particulate matter. The AERO CHROME* Select Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications. The AERO CHROME* A-Line Breathable 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 micro-organisms, body fluids, and particulate matter. The AERO CHROME* A-Line Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.

Source page: https://510kreport.com/device/K210688
Methodology: https://510kreport.com/methodology