510(k) · Cleared
ClearedVinyl Examination Glove, Powder-Free, Yellow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glormed Intl., Inc. · LYZ Vinyl Patient Examination Glove
Cleared on Aug 22, 2000 after a 21-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.
- Decided
- Aug 22, 2000
- Review
- 21 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 5 citing it directly.
- This deviceK002340 Vinyl Examination Glove, Powder-Free, YellowGlormed Intl., Inc. · 2000
- Descendant · cites it directly · 2 of its ownK021353 Powder-Free-Vinyl Examination Gloves, Color: WhiteGlormed Intl., Inc. · 2002
- Descendant · cites it directly · 1 of its ownK022305 Multiple Labels, Powder-Free Poly-Vinyl Exam Gloves, Color: WhiteHeyuan Hongli Industries, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK021961 Powder-Free Poly-Vinyl Exam Gloves, Color: WhiteCopioumed Intl., Inc. · 2002
- Descendant · cites it directly · 0 of its ownK041945 Powder-Free Blue Vinyl Exam GlovesGlormed Intl., Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK031104 Powdered Vinyl Exam Gloves, WhiteGlormed Intl., Inc. · 2003
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K021353Powder-Free-Vinyl Examination Gloves, Color: WhiteGlormed Intl., Inc. · 2002 · cites it directly2descendants
- K022305Multiple Labels, Powder-Free Poly-Vinyl Exam Gloves, Color: WhiteHeyuan Hongli Industries, Inc. · 2002 · cites it directly1descendant
- K021961Powder-Free Poly-Vinyl Exam Gloves, Color: WhiteCopioumed Intl., Inc. · 2002 · cites it directly1descendant
- K041945Powder-Free Blue Vinyl Exam GlovesGlormed Intl., Inc. · 2004 · cites it directly0descendants
- K031104Powdered Vinyl Exam Gloves, WhiteGlormed Intl., Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002340 | Vinyl Examination Glove, Powder-Free, Yellow | Glormed Intl., Inc. | 2000 | — |
| +1 | K021353 | Powder-Free-Vinyl Examination Gloves, Color: White | Glormed Intl., Inc. | 2002 | — |
| +1 | K022305 | Multiple Labels, Powder-Free Poly-Vinyl Exam Gloves, Color: White | Heyuan Hongli Industries, Inc. | 2002 | — |
| +1 | K021961 | Powder-Free Poly-Vinyl Exam Gloves, Color: White | Copioumed Intl., Inc. | 2002 | — |
| +1 | K041945 | Powder-Free Blue Vinyl Exam Gloves | Glormed Intl., Inc. | 2004 | — |
| +2 | K031104 | Powdered Vinyl Exam Gloves, White | Glormed Intl., Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
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.
Planning a device in LYZ? 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 LYZ device
- #1 K260860 Powder Free Synthetic Vinyl Exam Gloves (Blue…score 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021353 | Powder-Free-Vinyl Examination Gloves, Color: White | 2002 | 2 |
| K022305 | Multiple Labels, Powder-Free Poly-Vinyl Exam Gloves, Color: White | 2002 | 1 |
| K021961 | Powder-Free Poly-Vinyl Exam Gloves, Color: White | 2002 | 1 |
| K041945 | Powder-Free Blue Vinyl Exam Gloves | 2004 | 0 |
| K021743 | (Multiple Labels) Powder-Free Poly-Vinyl Exam Gloves, Color: Yellow | 2002 | 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?
- Of its descendants, K021353 (Glormed Intl., Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYZ
100in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYZ
2in 2025
MAUDE reports naming product code LYZ, 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 | 36 | 47 | 0 | 4 |
| 2008 | 18 | 90 | 0 | 0 |
| 2009 | 49 | 71 | 1 | 0 |
| 2010 | 72 | 66 | 0 | 2 |
| 2011 | 33 | 86 | 3 | 5 |
| 2012 | 25 | 84 | 1 | 5 |
| 2013 | 8 | 193 | 0 | 2 |
| 2014 | 40 | 226 | 0 | 6 |
| 2015 | 14 | 180 | 0 | 1 |
| 2016 | 11 | 145 | 1 | 11 |
| 2017 | 9 | 109 | 0 | 6 |
| 2018 | 10 | 80 | 0 | 0 |
| 2019 | 4 | 162 | 0 | 3 |
| 2020 | 4 | 85 | 0 | 1 |
| 2021 | 30 | 91 | 0 | 4 |
| 2022 | 10 | 100 | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K002340 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002340: Vinyl Examination Glove, Powder-Free, Yellow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002340
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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