# K080795: Ultra Surgical Gown & Fluid Barrier Surgical Gown

- Pathway: 510(k) (Abbreviated)
- Applicant: Kimberly-Clark Corp.
- Decided: Sep 3, 2008 after 167 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.
18 later devices descend from it; 5 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) KIMGUARD Surgical Gowns: named in the summary without a submission number
- (no number) SPUNGUARD Surgical Gowns: named in the summary without a submission number

## Most influential descendants
- K102652: Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns (2011), 8 descendants of its own
- K121152: Surgical Gown, SMS (2012), 7 descendants of its own
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants of its own
- K182172: Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) (2019), 2 descendants of its own
- K163191: ComfortGuard Surgical Gown, i600, Film Reinforced (2017), 1 descendant of its own

## Indications for use
The Kimberly-Clark* ULTRA Surgical Gowns and ULTRA Film-Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The ULTRA Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications, and the ULTRA Film-Reinforced Surgical Gowns meet Level 4 of the AAMI Liquid Barrier classifications.

Source page: https://510kreport.com/device/K080795
Methodology: https://510kreport.com/methodology