# K102500: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Nov 4, 2010 after 64 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 K013302 (2001). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013302: Duraprene Sterile Synthetic Powder-Free Surgical Gloves with Tested for Use with Chemotherapy Drugs Labeling Claim, Allegiance Healthcare Corp. (2001) Summary page 1.

## Most influential descendants
- K122557: Motex Powder-Free Nitrile Surgical Gloves (2013), 3 descendants of its own
- K140989: Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine) (2014), 2 descendants of its own
- K113707: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating (2012), 2 descendants of its own
- K170515: Sterile Nitrile Surgical Gloves, Powder-free (2017), 1 descendant of its own
- K153316: Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) (2016), 1 descendant of its own

## Indications for use
These powder-free sterile 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/K102500
Methodology: https://510kreport.com/methodology