# K052833: Gore-Tex Non-Sterile Surgical Gowns

- Pathway: 510(k) (Abbreviated)
- Applicant: Medline Industries, Inc.
- Decided: Feb 15, 2006 after 132 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
Medline Gore Panel Coverage Surgical Gowns and Gore Critical Coverage Surgical Gowns are surgical apparel 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 body fluids, micro-organisms, and particulate material. The surgical gowns are available in critical and panel coverage design with non-Gore-Tex panels comprised of a 100% polyester material.

Source page: https://510kreport.com/device/K052833
Methodology: https://510kreport.com/methodology