# K160875: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health, Inc.
- Decided: Jul 11, 2016 after 103 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: 4 generations back to K992171 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092304: Esteem Ortho Polyisoprene Powder-Free Surgical Gloves, Cardinal Health, Inc. (2009) Summary page 5.
- K151778: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating, Cardinal Health 200, Inc. (2016) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K160875
Methodology: https://510kreport.com/methodology