# K111868: Sterile Polyisoprene Powder-Free Blue Surgical Gloves with Neu-Thera Emollient Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health-Medical Products and Services
- Decided: Sep 21, 2011 after 82 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 K011721 (2001). 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)
- K042574: Esteem Blue Polyisoprene Surgical Gloves with Coating (Containing Chitosan, Provitamin B, Gluconolactone and Glycerol), Cardinalhealth (2004) Summary page 1.

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

Source page: https://510kreport.com/device/K111868
Methodology: https://510kreport.com/methodology