# K030536: Lac-Mac Limited Innerbloc O.R. Gown

- Pathway: 510(k) (Traditional)
- Applicant: Lac Mac, Ltd.
- Decided: May 6, 2003 after 75 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 Lac-Mac Limited InnerBloc® O.R. Gowns based on the RePeL PLUS™ and GORE® Surgical Barrier Fabric Materials, are reusable gowns that are intended to be worn 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/K030536
Methodology: https://510kreport.com/methodology