# K153316: Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: May 12, 2016 after 177 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: 3 generations back to K013302 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113707: Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating, Cardinal Health-Medical Products and Services (2012) Summary page 6.

## Most influential descendants
- K161823: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (2017), 0 descendants of its own

## Indications for use
A powder-free sterile 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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: CAUTION: Testing showed an average breakthrough time of 60.1 minutes with Carmustine

Source page: https://510kreport.com/device/K153316
Methodology: https://510kreport.com/methodology