# K092304: Esteem Ortho Polyisoprene Powder-Free Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Sep 15, 2009 after 48 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: 1 generation back to K010862 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011721: Esteem Sterile Polyisoprene Surgical Gloves, Allegiance Healthcare Corp. (2001)
- K010862: Ultrafree Max Sterile Latex Poweder-Free Surgical Gloves with Protein Labeling Claim, 50 Per Gram or Less of Total Water, Allegiance Healthcare Corp. (2001) Summary page 1.

## Most influential descendants
- K160875: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating (2016), 0 descendants of its own

## Indications for use
These powder-free surgeon's gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination in the environments within hospitals and other healthcare facilities.

Source page: https://510kreport.com/device/K092304
Methodology: https://510kreport.com/methodology