# K093115: Kimberly-Clark KC100 Surgical Gown, Model KC100

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Mar 19, 2010 after 168 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 K091097 (2009). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091097: Promedical Surgical Gown, Models 18-301, 18-401 and 18-501, Promedical Products Co., Ltd. (2009) Summary page 1.

## 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
- K141467: Surgical Gown (2015), 1 descendant of its own
- K253003: Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (2026), 0 descendants of its own

## Indications for use
The Kimberly-Clark* KC100 Surgical Gowns are sterile, single use devices 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 Kimberly-Clark* KC100 Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Source page: https://510kreport.com/device/K093115
Methodology: https://510kreport.com/methodology