# K150151: SmartGownTM surgical gown

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health 200, Inc.
- Decided: May 21, 2015 after 118 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: 1 generation back to K012984 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012984: Breathable Impervious Gowns, Allegiance Healthcare Corp. (2001) Summary page 3.

## Recalls of this device
- Nov 2, 2021 · Class II · Z-0368-2022: Potential for open packaging seals compromising the sterility of the surgical gowns

## Indications for use
Cardinal Health SmartGown™ surgical gown surgical gown is 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 Cardinal Health SmartGown™ surgical gown surgical gown is a single use, disposable medical device provided sterile and non-sterile, This submission covers 12 models of Cardinal Health SmartGown™ surgical gown, see Table 1. Each model is a multi-layer construction of a nonwoven outer layer, breathable film core and a nonwoven inner layer, and has been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.

Source page: https://510kreport.com/device/K150151
Methodology: https://510kreport.com/methodology