# K012240: Mertex-Plus O.R./Surgeons Gown, Nonsterile

- Pathway: 510(k) (Traditional)
- Applicant: Mercan AB
- Decided: Oct 15, 2001 after 90 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sewing Source O.R./Surgeon's Gowns, based on the both the Maxima ESD and Mertex-Plus E3333-R materials, are reusable gowns that are intended to be womn 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. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.

Source page: https://510kreport.com/device/K012240
Methodology: https://510kreport.com/methodology