# K200824: Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Jul 29, 2020 after 121 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ SMARTGOWN™ Breathable Surgical Gown and Cardinal Health™ SMARTGOWN™ AIR Breathable Surgical Gown are single use, disposable medical devices provided sterile and non-sterile.

Source page: https://510kreport.com/device/K200824
Methodology: https://510kreport.com/methodology