# K253243: Cardinal Health™ Poly Reinforced Surgical Gown

- Pathway: 510(k) (Abbreviated)
- Applicant: Cardinal Health 200, LLC
- Decided: Apr 28, 2026 after 211 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™ Poly Reinforced 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 gowns meet the barrier protection requirements of AAMI Level 4 per AAMI PB70 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities. The Cardinal Health™ Poly Reinforced Surgical Gown is a single use, disposable medical device provided sterile and non-sterile. Non-sterile gowns are intended for distribution to re-packager/re-labeler establishments for further packaging and sterilization using a validated ethylene oxide (EO) sterilization method in accordance with ISO 11135 prior to being provided to the end user.

Source page: https://510kreport.com/device/K253243
Methodology: https://510kreport.com/methodology