# K170198: Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Jun 15, 2017 after 143 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 K011721 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug, Cardinal Health, Inc. (2011) Summary page 4.

## 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:

Source page: https://510kreport.com/device/K170198
Methodology: https://510kreport.com/methodology