# K160974: Gammex Cut-Resistant Glove Liner

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: Oct 28, 2016 after 204 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 K922407 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922407: Wells Lamont Cut Resistant Surgical Glove Liners, Wells Lamont Corp. (1993) Summary page 4.

## Most influential descendants
- K190782: FlexGard Cut-Resistant Glove Liners (2019), 0 descendants of its own

## Indications for use
The Gammex(R) Cut Resistant Glove Liner is a single use glove liner intended to provide ANSI/ISEA 105 Cut Level Protection 2 against cuts when used with an inner and outer surgical glove. The glove liner should be worn between two surgical gloves.

Source page: https://510kreport.com/device/K160974
Methodology: https://510kreport.com/methodology