# K032631: Innerbloc LR Surgical Gowns Based on Gore LR Fabric (Reusable 100X)

- Pathway: 510(k) (Traditional)
- Applicant: Lac Mac, Ltd.
- Decided: Feb 5, 2004 after 163 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® LR Surgical Gowns, based on the GORE® LR Fabric, are reusable gowns that are intended to be worn by health care personnel during surgical and other medical 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/K032631
Methodology: https://510kreport.com/methodology