# K111878: Protexis Latex Blue with Neu-Thera Powder-Free Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Sep 29, 2011 after 90 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001924 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053272: Cardinal Health Protegrity Blue with Neu-Thera Surgical Gloves, Cardinalhealth (2006) Summary page 1.

## Indications for use
This powder-free surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K111878
Methodology: https://510kreport.com/methodology