# K041540: Combosafe (Europe) and Promax (US) Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Standard Textile Co., Inc.
- Decided: May 5, 2005 after 331 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
COMBOsafe/PromaX Surgical Gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown. COMBOsafe/Promax Surgical Gowns will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be 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/K041540
Methodology: https://510kreport.com/methodology