# K012268: Trimax

- Pathway: 510(k) (Traditional)
- Applicant: Standard Textile Co., Inc.
- Decided: Dec 3, 2001 after 137 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 K922753 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922753: Compel XTR, Standard Textile Co., Inc. (1993) Summary page 1.

## Indications for use
TriMax Surgical Gown are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.

Source page: https://510kreport.com/device/K012268
Methodology: https://510kreport.com/methodology