# K180217: VESTEX Apparel

- Pathway: 510(k) (Traditional)
- Applicant: Vestagen Protective Technologies, Inc.
- Decided: May 18, 2018 after 113 days
- Product code: QBW (Surgical Apparel With Material Claims)
- 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
Longest line of descent: 1 generation back to K891212 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891212: Aprons, Scrubs Slacks & Tops, Patient Drape, Pro-Safe Professional Linens, Inc. (1989) Summary page 4.

## Indications for use
VESTEX® Apparel (“VESTEX”), scrub tops, pants, skirts, and lab coats are apparel that provides fluid repellency and reduces the retention of Methicillin Resistant Staphylococcus aureus (MRSA) on the surface (outer layer) of the apparel. The ability of VESTEX to reduce the retention of MRSA on the fabric surface has not been shown to correlate with the reduction of infections. Clinical studies to evaluate reduction in infection have not been performed for this device. VESTEX Apparel is not intended to replace personal protective equipment.

Source page: https://510kreport.com/device/K180217
Methodology: https://510kreport.com/methodology