# K151778: Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health 200, Inc.
- Decided: Mar 24, 2016 after 267 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 K992171 (1999). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111015: Sterile Latex Powder Free Surgical Gloves with Hydrogel Coating, Cardinal Health, Inc. (2011) Summary page 5.
- K903987: Triflex (R) Orth Sterile Surgeon's Gloves, Modified, Baxter Healthcare Corp (1990) Summary page 5.

## 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
A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K151778
Methodology: https://510kreport.com/methodology