510(k) · Cleared
ClearedSynthetic (White) Vinal Powdered Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Great Eagle Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Feb 22, 2000 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Feb 22, 2000
- Review
- 34 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK000166 Synthetic (White) Vinal Powdered Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
- Descendant · cites it directly · 0 of its ownK070027 Powdered (White) Vinyl Patient ExaminationShijiazhuang Lianhe Shunda Plastic Products Co., L · 2007
- Descendant · cites it directly · 0 of its ownK070040 Powdered Vinyl Patient Examination Gloves, WhiteSuper Safe Plastic Products Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK063214 Ever Light Plastic Products CO., LTD. Powdered (White) Vinyl Patient…Ever Light Plastic Products Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK062655 Powdered (White) Vinyl Patient Examination GlovesShijiazhuang Junfei Plastic Products Co., Ltd. · 2006
Most influential descendants
Showing 4 of 4 · See all- K070027Powdered (White) Vinyl Patient ExaminationShijiazhuang Lianhe Shunda Plastic Products Co., L · 2007 · cites it directly0descendants
- K070040Powdered Vinyl Patient Examination Gloves, WhiteSuper Safe Plastic Products Co., Ltd. · 2007 · cites it directly0descendants
- K063214Ever Light Plastic Products CO., LTD. Powdered (White) Vinyl Patient Examination GlovesEver Light Plastic Products Co., Ltd. · 2006 · cites it directly0descendants
- K062655Powdered (White) Vinyl Patient Examination GlovesShijiazhuang Junfei Plastic Products Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000166 | Synthetic (White) Vinal Powdered Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000 | — |
| +1 | K070027 | Powdered (White) Vinyl Patient Examination | Shijiazhuang Lianhe Shunda Plastic Products Co., L | 2007 | — |
| +1 | K070040 | Powdered Vinyl Patient Examination Gloves, White | Super Safe Plastic Products Co., Ltd. | 2007 | — |
| +1 | K063214 | Ever Light Plastic Products CO., LTD. Powdered (White) Vinyl Patient… | Ever Light Plastic Products Co., Ltd. | 2006 | — |
| +1 | K062655 | Powdered (White) Vinyl Patient Examination Gloves | Shijiazhuang Junfei Plastic Products Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 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? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070027 | Powdered (White) Vinyl Patient Examination | 2007 | 0 |
| K070040 | Powdered Vinyl Patient Examination Gloves, White | 2007 | 0 |
| K063214 | Ever Light Plastic Products CO., LTD. Powdered (White) Vinyl Patient Examination Gloves | 2006 | 0 |
| K062655 | Powdered (White) Vinyl Patient Examination Gloves | 2006 | 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, K070027 (Shijiazhuang Lianhe Shunda Plastic Products Co., L, 2007) has gone furthest, with 0 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/K000166 · printed Nov 5, 2026
Cite this page
510(k) Report. “K000166: Synthetic (White) Vinal Powdered Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000166
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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