510(k) · Cleared
ClearedPowder-Free Vinyl Patient Examintion Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Manful Light Industrial Products Co., · LYZ Vinyl Patient Examination Glove
Cleared on Nov 3, 2004 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Nov 3, 2004
- Review
- 89 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 1 citing it directly.
- This deviceK042119 Powder-Free Vinyl Patient Examintion GlovesShijiazhuang Manful Light Industrial Products Co., · 2004
- Descendant · cites it directly · 28 of its ownK051156 Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow)Shijiazhuang Manful Light Industrial Products Co., · 2005
- Descendant · 2 generations on · 7 of its ownK122920 Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)Hebei Leader Plastic Co., Ltd. · 2012
- Descendant · 2 generations on · 3 of its ownK110945 Powder-Free Yellow Synthetic Vinyl Patient Examination GlovesZhaoyang Plastic Co., Ltd. · 2011
- Descendant · 2 generations on · 3 of its ownK102558 Powder Free Vinyl Patient Examination Gloves, Colored (White)Tangshan Hengda Plastic Products Co., Ltd. · 2010
- Descendant · 3 generations on · 1 of its ownK141878 Hongyun Powder-Free Yellow Vinyl Patient Examination GlovesTangshan Hongyun Plastic Products Co., Ltd. · 2014
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K051156Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow)Shijiazhuang Manful Light Industrial Products Co., · 2005 · cites it directly28descendants
- K122920Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)Hebei Leader Plastic Co., Ltd. · 2012 · 2 generations on7descendants
- K110945Powder-Free Yellow Synthetic Vinyl Patient Examination GlovesZhaoyang Plastic Co., Ltd. · 2011 · 2 generations on3descendants
- K102558Powder Free Vinyl Patient Examination Gloves, Colored (White)Tangshan Hengda Plastic Products Co., Ltd. · 2010 · 2 generations on3descendants
- K141878Hongyun Powder-Free Yellow Vinyl Patient Examination GlovesTangshan Hongyun Plastic Products Co., Ltd. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042119 | Powder-Free Vinyl Patient Examintion Gloves | Shijiazhuang Manful Light Industrial Products Co., | 2004 | — |
| +1 | K051156 | Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow) | Shijiazhuang Manful Light Industrial Products Co., | 2005 | — |
| +2 | K122920 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) | Hebei Leader Plastic Co., Ltd. | 2012 | — |
| +2 | K110945 | Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves | Zhaoyang Plastic Co., Ltd. | 2011 | — |
| +2 | K102558 | Powder Free Vinyl Patient Examination Gloves, Colored (White) | Tangshan Hengda Plastic Products Co., Ltd. | 2010 | — |
| +3 | K141878 | Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves | Tangshan Hongyun Plastic Products Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2010 | 11 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051156 | Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow) | 2005 | 28 |
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, K051156 (Shijiazhuang Manful Light Industrial Products Co.,, 2005) has gone furthest, with 28 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/K042119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042119: Powder-Free Vinyl Patient Examintion Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042119
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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