# K151694: Gammex PI Hybrid Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Mar 9, 2016 after 260 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 K071746 (2007). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071746: Derma Prene PI or Isotouch Green Sterile Powder-Free Synthetic Polyisoprene Surgical Gloves, Ansell Healthcare Products, LLC (2007) Summary page 4.

## Most influential descendants
- K171047: Sterile Polyisoprene Powder Free Surgical Gloves (2017), 2 descendants of its own
- K182948: Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (2019), 1 descendant of its own
- K231902: GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090) (2023), 0 descendants of its own
- K230304: Polyisoprene Surgical Gloves (2023), 0 descendants of its own
- K203483: Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves (2021), 0 descendants of its own

## Indications for use
Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K151694
Methodology: https://510kreport.com/methodology