510(k) · Cleared
ClearedSynthetic Powder Free (Yellow) Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Hongxiang Plastics Products Co;, Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jun 30, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 30, 2000
- Review
- 14 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK001834 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Hongxiang Plastics Products Co;, Ltd. · 2000
- Descendant · cites it directly · 5 of its ownK042247 Synthetic (Blue) Vinyl Patient Examination Gloves - Powder FreeShijiazhuang Hongxiang Plastics Products Co., Ltd. · 2004
- Descendant · 2 generations on · 4 of its ownK061562 Vinyl CO-Polymer Powder Free Examination Gloves, Blue ColorGrand Work Plastic Products Co., Ltd. · 2006
- Descendant · 3 generations on · 1 of its ownK142409 Vinyl Co-Polymer Powder Free Examination GlovesGrand Work Plastic Products Co., Ltd. · 2014
- Descendant · 4 generations on · 0 of its ownK220240 Vinyl Co-Polymer Powder-free Examination Gloves, BlackGrand Work Plastic Products Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK092294 Vinyl CO-Polmer Free Examination Gloves, Blue ColorBettercare Plastic Products Co., Ltd. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042247Synthetic (Blue) Vinyl Patient Examination Gloves - Powder FreeShijiazhuang Hongxiang Plastics Products Co., Ltd. · 2004 · cites it directly5descendants
- K061562Vinyl CO-Polymer Powder Free Examination Gloves, Blue ColorGrand Work Plastic Products Co., Ltd. · 2006 · 2 generations on4descendants
- K142409Vinyl Co-Polymer Powder Free Examination GlovesGrand Work Plastic Products Co., Ltd. · 2014 · 3 generations on1descendant
- K220240Vinyl Co-Polymer Powder-free Examination Gloves, BlackGrand Work Plastic Products Co., Ltd. · 2022 · 4 generations on0descendants
- K092294Vinyl CO-Polmer Free Examination Gloves, Blue ColorBettercare Plastic Products Co., Ltd. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001834 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co;, Ltd. | 2000 | — |
| +1 | K042247 | Synthetic (Blue) Vinyl Patient Examination Gloves - Powder Free | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2004 | — |
| +2 | K061562 | Vinyl CO-Polymer Powder Free Examination Gloves, Blue Color | Grand Work Plastic Products Co., Ltd. | 2006 | — |
| +3 | K142409 | Vinyl Co-Polymer Powder Free Examination Gloves | Grand Work Plastic Products Co., Ltd. | 2014 | — |
| +4 | K220240 | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Grand Work Plastic Products Co., Ltd. | 2022 | — |
| +3 | K092294 | Vinyl CO-Polmer Free Examination Gloves, Blue Color | Bettercare Plastic Products Co., Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042247 | Synthetic (Blue) Vinyl Patient Examination Gloves - Powder Free | 2004 | 5 |
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, K042247 (Shijiazhuang Hongxiang Plastics Products Co., Ltd., 2004) has gone furthest, with 5 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/K001834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001834: Synthetic 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/K001834
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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