# K193327: Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Mar 20, 2020 after 109 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: 2 generations back to K880382 (1988). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052824: Kimberly-Clark Procedure Gown, Kimberly-Clark Corp. (2006) Summary page 6.

## Most influential descendants
- K214108: Medline Orbis Chemo Surgical Gown (2022), 0 descendants of its own

## Recalls of this device
- Nov 12, 2025 · Class II · Z-0897-2026: Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

## Indications for use
The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Closed Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. The closed back gowns are single use, disposable medical devices provided sterile and non-sterile. The non-sterile, closed back gowns are not intended for use in the operating room. The Cardinal Health™ ChemoPlus™ Full Coverage Gowns, Open Back, are intended to protect healthcare personnel from exposure to chemotherapy drugs during preparation, handling, and administration. The open back gowns are single use, disposable medical devices provided non-sterile. The open back gown is nonprotective in the back. The open back gowns are not intended for use in the operating room.

Source page: https://510kreport.com/device/K193327
Methodology: https://510kreport.com/methodology