# K052824: Kimberly-Clark Procedure Gown

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: May 2, 2006 after 209 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: 1 generation back to K880382 (1988). 1 ancestor in all.
2 later devices descend 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)
- K880382: Kimberly-Clark Impervious Open Back Gown, Kimberly-Clark Corp. (1988) Summary page 1.

## Most influential descendants
- K193327: Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve (2020), 1 descendant of its own
- K214108: Medline Orbis Chemo Surgical Gown (2022), 0 descendants of its own

## Indications for use
The Kimberly-Clark Procedure Gown is a non-sterile, disposable, single use item of apparel intended to be worn by healthcare professionals during the preparation and administration of selected chemotherapy drugs. The gown is not intended to be worn during surgical procedures.

Source page: https://510kreport.com/device/K052824
Methodology: https://510kreport.com/methodology