# K880382: Kimberly-Clark Impervious Open Back Gown

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Jun 23, 1988 after 147 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.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052824: Kimberly-Clark Procedure Gown (2006), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K880382
Methodology: https://510kreport.com/methodology