510(k) · Cleared
ClearedPowder-Free, Yellow Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zibo Yusheng Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jul 8, 2009 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 35 later devices descend from it.
- Decided
- Jul 8, 2009
- Review
- 56 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
35 later devices descend from it, 1 citing it directly.
- This deviceK091431 Powder-Free, Yellow Vinyl Patient Examination GlovesZibo Yusheng Plastic Products Co., Ltd. · 2009
- Descendant · cites it directly · 34 of its ownK142508 Powder Free Yellow Vinyl Patient Examination GlovesZibo Huaqi Trading Co., Ltd. · 2014
- Descendant · 2 generations on · 33 of its ownK150224 Blue Vinyl Gloves Powder FreeZibo Sanying Trade Co., Ltd. · 2015
- Descendant · 3 generations on · 30 of its ownK163168 Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue)…Hebei Hongtai Plastic Products Company Limited · 2017
- Descendant · 4 generations on · 9 of its ownK180861 Vinyl Examination Glove (Clear, Non-Colored)Zhicheng Trading Co., Ltd. · 2018
- Descendant · 4 generations on · 4 of its ownK180849 Vinyl Examination Glove (Clear, Non-Colored)Huifu Trading Co., Ltd. · 2018
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K142508Powder Free Yellow Vinyl Patient Examination GlovesZibo Huaqi Trading Co., Ltd. · 2014 · cites it directly34descendants
- K150224Blue Vinyl Gloves Powder FreeZibo Sanying Trade Co., Ltd. · 2015 · 2 generations on33descendants
- K163168Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination…Hebei Hongtai Plastic Products Company Limited · 2017 · 3 generations on30descendants
- K180861Vinyl Examination Glove (Clear, Non-Colored)Zhicheng Trading Co., Ltd. · 2018 · 4 generations on9descendants
- K180849Vinyl Examination Glove (Clear, Non-Colored)Huifu Trading Co., Ltd. · 2018 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091431 | Powder-Free, Yellow Vinyl Patient Examination Gloves | Zibo Yusheng Plastic Products Co., Ltd. | 2009 | — |
| +1 | K142508 | Powder Free Yellow Vinyl Patient Examination Gloves | Zibo Huaqi Trading Co., Ltd. | 2014 | — |
| +2 | K150224 | Blue Vinyl Gloves Powder Free | Zibo Sanying Trade Co., Ltd. | 2015 | — |
| +3 | K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl… | Hebei Hongtai Plastic Products Company Limited | 2017 | — |
| +4 | K180861 | Vinyl Examination Glove (Clear, Non-Colored) | Zhicheng Trading Co., Ltd. | 2018 | — |
| +4 | K180849 | Vinyl Examination Glove (Clear, Non-Colored) | Huifu Trading Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 13 | 0 |
| 2022 | 6 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142508 | Powder Free Yellow Vinyl Patient Examination Gloves | 2014 | 34 |
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, K142508 (Zibo Huaqi Trading Co., Ltd., 2014) has gone furthest, with 34 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. 2009, this device’s year, is highlighted.
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 purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091431: Powder-Free, Yellow Vinyl Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091431
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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