510(k) · Cleared
ClearedDisposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai PM Plastics Enterise Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Dec 18, 2002 after a 12-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Dec 18, 2002
- Review
- 12 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK024026 Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera…Shanghai PM Plastics Enterise Co., Ltd. · 2002
- Descendant · cites it directly · 2 of its ownK042830 Powder Free Vinyl Synthetic Examination GlovesGrand Work Plastic Products Co., Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK092302 Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green…Bettercare Plastic Products Co., Ltd. · 2010
- Descendant · 2 generations on · 0 of its ownK060785 Powder Free Vinyl Synthetic Examination Gloves W/Aloe Vera, Green…Ever Light Plastic Products Co., Ltd. · 2006
Most influential descendants
Showing 3 of 3 · See all- K042830Powder Free Vinyl Synthetic Examination GlovesGrand Work Plastic Products Co., Ltd. · 2004 · cites it directly2descendants
- K092302Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green ColorBettercare Plastic Products Co., Ltd. · 2010 · 2 generations on0descendants
- K060785Powder Free Vinyl Synthetic Examination Gloves W/Aloe Vera, Green ColorEver Light Plastic Products Co., Ltd. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024026 | Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color | Shanghai PM Plastics Enterise Co., Ltd. | 2002 | — |
| +1 | K042830 | Powder Free Vinyl Synthetic Examination Gloves | Grand Work Plastic Products Co., Ltd. | 2004 | — |
| +2 | K092302 | Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color | Bettercare Plastic Products Co., Ltd. | 2010 | — |
| +2 | K060785 | Powder Free Vinyl Synthetic Examination Gloves W/Aloe Vera, Green Color | Ever Light Plastic Products Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042830 | Powder Free Vinyl Synthetic Examination Gloves | 2004 | 2 |
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, K042830 (Grand Work Plastic Products Co., Ltd., 2004) 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 | — |
What is it indicated for?
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PRWENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K024026 · printed Nov 5, 2026
Cite this page
510(k) Report. “K024026: Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K024026
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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