# K031362: Lac-Mac Limited Innerbloc Various O.R. Drape Based on  the Repel, Plus and Gore Surgical Barrier Fabric Materials

- Pathway: 510(k) (Traditional)
- Applicant: Lac Mac, Ltd.
- Decided: May 30, 2003 after 99 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 Lac-Mac Limited InnerBloc@O.R. Drapes based on the RePeL PLUSTM and GORE@ Surgical Barrier Fabric Materials, are reusable protective patient coverings for isolating sites of surgical incisions from microbial or other contamination. For manufacturing, processing, or repackaging, these drapes must be reprocessed and packaged.

Source page: https://510kreport.com/device/K031362
Methodology: https://510kreport.com/methodology