# K012237: Mertex-Plus Reusable Surgical Drape

- Pathway: 510(k) (Traditional)
- Applicant: Mercan AB
- Decided: Oct 15, 2001 after 90 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- 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 Custom Reusable Surgical Drapes, based on the both the Maxima ESD-AT and Mertex-Plus E5533-R materials, are reusable protective patient covering for isolating sites of surgical incisions from microbial or other contarination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.

Source page: https://510kreport.com/device/K012237
Methodology: https://510kreport.com/methodology