510(k) Report

510(k) · Cleared

Cleared

Wells Lamont Cut Resistant Surgical Glove Liners

K922407510(k) TraditionalCleared Jun 15, 1993390-day reviewClass I21 CFR 878.4040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wells Lamont Corp. · LYU Accessory, Surgical Apparel

Cleared on Jun 15, 1993 after a 390-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 15, 1993
Review
390 days
Class
Class I
Product code
LYU
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2007: 1 descendant cleared2019: 1 descendant cleared1990200020102020
  1. This deviceK922407 Wells Lamont Cut Resistant Surgical Glove LinersWells Lamont Corp. · 1993
  2. Descendant · cites it directly · 1 of its ownK160974 Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC · 2016
  3. Descendant · 2 generations on · 0 of its ownK190782 FlexGard Cut-Resistant Glove LinersLdi Corporation · 2019
  4. Descendant · cites it directly · 0 of its ownK063582 Zimmer Cut Resistant Glove Liner, Xsmall, Small, Medium, Large, XlargeZimmer, Inc. · 2007

Most influential descendants

Showing 3 of 3 · See all
  • K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC · 2016 · cites it directly1descendant
  • K190782FlexGard Cut-Resistant Glove LinersLdi Corporation · 2019 · 2 generations on0descendants
  • K063582Zimmer Cut Resistant Glove Liner, Xsmall, Small, Medium, Large, XlargeZimmer, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922407Wells Lamont Cut Resistant Surgical Glove LinersWells Lamont Corp.1993—
+1K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC2016—
+2K190782FlexGard Cut-Resistant Glove LinersLdi Corporation2019—
+1K063582Zimmer Cut Resistant Glove Liner, Xsmall, Small, Medium, Large, XlargeZimmer, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201610
201910
FIG. 1 — Lineage of K922407, 1993–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC20161
K063582Zimmer Cut Resistant Glove Liner, Xsmall, Small, Medium, Large, XlargeZimmer, Inc.20070

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?

  • Of its descendants, K160974 (Ansell Healthcare Products, LLC, 2016) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LYU devices

LYU Accessory, Surgical Apparel: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LYU

FDA has decided no LYU device since 2007.

Median 510(k) review, days · LYU

Too few LYU 510(k)s in any year since 2007 to give a median.

Recalls per year · LYU

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYU

5in 2025

2007: 12008: 42011: 52012: 32013: 132014: 72015: 12016: 492017: 112018: 12019: 12020: 92021: 22022: 42024: 32025: 5
2007high 49 (2016) · low 0 (2009)2025

MAUDE reports naming product code LYU, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—04
20090—00
20100—00
20110—05
20120—03
20130—013
20140—07
20150—01
20160—049
20170—111
20180—01
20190—01
20200—09
20210—02
20220—04
20230—00
20240—03
20250—05
20260—0—

More from Wells Lamont Corp.

4 FDA decisions under this applicant name. See the company

  • K944763Cut-Tec or Wells Lamont Polyester/Wire Cut-Resistant Glove Liner Wells-Tec, ScepterWells Lamont Corp. · 1995
  • K940274Nylon Liner GlovesWells Lamont Corp. · 1994
  • K925937Wells Lamont Handages/Med Wrap DressingsWells Lamont Corp. · 1993

Recent decisions in LYU

The LYU category page

  • K011755Stryker T4 Hytrel (R) TogasStryker Corp. · 2001
  • K965237Nurses Bouffant CapCopioumed Intl., Inc. · 1997
  • K970988Far-East Bouffant CapsFar East Science & Technology Development Co., Ltd. · 1997
  • K964364Disposable ApronInstrument Makar, Inc. · 1997
  • K961791Depuy Disposable Filter/HoodDepuy, Inc. · 1996

https://510kreport.com/device/K922407 · printed Nov 4, 2026

Cite this page

510(k) Report. “K922407: Wells Lamont Cut Resistant Surgical Glove Liners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K922407

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026