# K190782: FlexGard Cut-Resistant Glove Liners

- Pathway: 510(k) (Abbreviated)
- Applicant: Ldi Corporation
- Decided: Jun 27, 2019 after 92 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: 2 generations back to K922407 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160974: Gammex Cut-Resistant Glove Liner, Ansell Healthcare Products, LLC (2016) Summary page 4.

## Indications for use
The FlexGard® Cut-Resistant Glove Liners are single use glove liners intended to help with protection against cuts when used with an inner and outer surgical glove. The glove liner must be worn between two surgical gloves.

Source page: https://510kreport.com/device/K190782
Methodology: https://510kreport.com/methodology