510(k) · Cleared
ClearedGammex Cut-Resistant Glove Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare Products, LLC · KGO Surgeon'S Gloves
Cleared on Oct 28, 2016 as substantially equivalent to K922407 (Wells Lamont Corp., 1993) after a 204-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Oct 28, 2016
- Review
- 204 days
- Class
- Class I
- Product code
- KGO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922407 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK922407 Wells Lamont Cut Resistant Surgical Glove LinersWells Lamont Corp. · 1993
- This deviceK160974 Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC · 2016
- Descendant · cites it directly · 0 of its ownK190782 FlexGard Cut-Resistant Glove LinersLdi Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K190782FlexGard Cut-Resistant Glove LinersLdi Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922407 | Wells Lamont Cut Resistant Surgical Glove Liners | Wells Lamont Corp. | 1993 | — |
| 0 (this device) | K160974 | Gammex Cut-Resistant Glove Liner | Ansell Healthcare Products, LLC | 2016 | — |
| +1 | K190782 | FlexGard Cut-Resistant Glove Liners | Ldi Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGO device
- #1 K192328 JR.MEDIK Latex Surgeon’s Gloves Powder Freescore 15.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K922407 | Wells Lamont Cut Resistant Surgical Glove LinersSummary page 4…class: I Product code: KGO Classification panel: General and plastic surgery Legally marketed predicate device: K922407 – Wells Lamont Cut Resistant Surgical Glove Liners Device description: Cut resistant under glove liner is a white color liner kn… | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190782 | FlexGard Cut-Resistant Glove Liners | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KGO devicesKGO Surgeon'S Gloves: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KGO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGO
185in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGO
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGO
21in 2025
MAUDE reports naming product code KGO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 113 | 0 | 13 |
| 2008 | 2 | — | 0 | 8 |
| 2009 | 3 | 48 | 15 | 14 |
| 2010 | 6 | 87 | 1 | 16 |
| 2011 | 11 | 90 | 0 | 14 |
| 2012 | 7 | 133 | 0 | 14 |
| 2013 | 6 | 184 | 0 | 41 |
| 2014 | 7 | 257 | 0 | 28 |
| 2015 | 12 | 225 | 0 | 11 |
| 2016 | 9 | 218 | 2 | 15 |
| 2017 | 12 | 111 | 1 | 20 |
| 2018 | 7 | 194 | 8 | 15 |
| 2019 | 11 | 204 | 0 | 51 |
| 2020 | 15 | 117 | 0 | 15 |
| 2021 | 14 | 199 | 0 | 14 |
| 2022 | 6 | 127 | 2 | 10 |
| 2023 | 14 | 185 | 2 | 28 |
| 2024 | 2 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 21 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160974 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160974: Gammex Cut-Resistant Glove Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160974
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026