# K981393: Microcool Surgical Gown

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Jul 10, 1998 after 84 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.
13 later devices descend from it; 3 cite it directly.
0 of 14 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) 3M Prevention Fabric Surgical Gown: named in the summary without a submission number

## Most influential descendants
- K091357: Microcool Surgical Gown, Breathable High Performance KC400 (2009), 8 descendants of its own
- K103406: Microcool Breathable High Performance Surgical Gowns (2010), 7 descendants of its own
- 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

## Indications for use
The MicroCool Surgical Gown and the MicroCool Isolation Gown are single use items of surgical apparel intended to be worn by health care professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

Source page: https://510kreport.com/device/K981393
Methodology: https://510kreport.com/methodology