# K103406: Microcool Breathable High Performance Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Dec 23, 2010 after 34 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K981393 (1998). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091357: Microcool Surgical Gown, Breathable High Performance KC400, Kimberly-Clark Corp. (2009) Summary page 1.

## Most influential descendants
- K140539: Aero Blue Performance Surgical Gown (2014), 6 descendants of its own
- K153255: Aero Chrome* Breathable Performance Surgical Gown (2016), 4 descendants of its own
- K200522: AERO CHROME* Breathable Performance Surgical Gowns (2020), 2 descendants of its own
- K260725: BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) (2026), 0 descendants of its own
- K210688: AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown (2021), 0 descendants of its own

## Recalls of this device
- Jul 5, 2012 · Class II · Z-0257-2013: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
- Jul 5, 2012 · Class II · Z-0258-2013: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.

## Indications for use
The Kimberly-Clark t MicroCool t Surgical Gowns, are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The MicroCool t Surgical Gown meets the Level 4 requirements of the AAMI Liquid Barrier classifications. The Kimberly-Clark t MicroCool t 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/K103406
Methodology: https://510kreport.com/methodology