510(k) · Cleared
ClearedVinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cheer & Merit Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jul 20, 1995 after a 464-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 62 later devices descend from it.
- Decided
- Jul 20, 1995
- Review
- 464 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
62 later devices descend from it, 2 citing it directly.
- This deviceK941809 Vinyl Patient Examination GlovesCheer & Merit Co., Ltd. · 1995
- Descendant · cites it directly · 61 of its ownK960746 Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. GlovesSunmax Enterprise Shanghai Co., Ltd. · 1996
- Descendant · cites it directly · 60 of its ownK974151 Vinyl Patient Examination Gloves (Powdered)Shanghai Super Gloves Co., Ltd. · 1997
- Descendant · 2 generations on · 51 of its ownK983645 Synthetic Powdered Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1998
- Descendant · 3 generations on · 40 of its ownK011884 Powdered Synthetic Vinyl Patient Examination GlovesShijiazhuang Eversharp Plastic Products Co., Ltd. · 2001
- Descendant · 4 generations on · 38 of its ownK032907 Fuguan (Brand) Powdered Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K960746Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. GlovesSunmax Enterprise Shanghai Co., Ltd. · 1996 · cites it directly61descendants
- K974151Vinyl Patient Examination Gloves (Powdered)Shanghai Super Gloves Co., Ltd. · 1997 · cites it directly60descendants
- K983645Synthetic Powdered Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1998 · 2 generations on51descendants
- K011884Powdered Synthetic Vinyl Patient Examination GlovesShijiazhuang Eversharp Plastic Products Co., Ltd. · 2001 · 3 generations on40descendants
- K032907Fuguan (Brand) Powdered Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003 · 4 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941809 | Vinyl Patient Examination Gloves | Cheer & Merit Co., Ltd. | 1995 | — |
| +1 | K960746 | Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves | Sunmax Enterprise Shanghai Co., Ltd. | 1996 | — |
| +1 | K974151 | Vinyl Patient Examination Gloves (Powdered) | Shanghai Super Gloves Co., Ltd. | 1997 | — |
| +2 | K983645 | Synthetic Powdered Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998 | — |
| +3 | K011884 | Powdered Synthetic Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001 | — |
| +4 | K032907 | Fuguan (Brand) Powdered Vinyl Patient Examination Gloves | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 8 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2013 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (62)
See all 622 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K960746 (Sunmax Enterprise Shanghai Co., Ltd., 1996) has gone furthest, with 61 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/K941809 · printed Nov 5, 2026
Cite this page
510(k) Report. “K941809: Vinyl 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/K941809
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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