510(k) · Cleared
ClearedSunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunmax Enterprise Shanghai Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jun 27, 1996 as substantially equivalent to K893822 (Honyee Enterprise Co., 1989) and 1 other predicate after a 125-day review. Its family tree reaches back 1 generation to 1989. 61 later devices descend from it.
- Decided
- Jun 27, 1996
- Review
- 125 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893822 (1989). 2 ancestors in all. 61 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK893822 Honyee Vinyl Examination GlovesHonyee Enterprise Co. · 1989
- This deviceK960746 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 · cites it directly · 51 of its ownK983645 Synthetic Powdered Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1998
- Descendant · 2 generations on · 40 of its ownK011884 Powdered Synthetic Vinyl Patient Examination GlovesShijiazhuang Eversharp Plastic Products Co., Ltd. · 2001
- Descendant · 3 generations on · 38 of its ownK032907 Fuguan (Brand) Powdered Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
- Descendant · 4 generations on · 6 of its ownK091662 Powdered Vinyl Patient Examination GlovesZhangjiagang Fengyuan Plastic Products Co., Ltd. · 2009
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- 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 · cites it directly51descendants
- K011884Powdered Synthetic Vinyl Patient Examination GlovesShijiazhuang Eversharp Plastic Products Co., Ltd. · 2001 · 2 generations on40descendants
- K032907Fuguan (Brand) Powdered Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003 · 3 generations on38descendants
- K091662Powdered Vinyl Patient Examination GlovesZhangjiagang Fengyuan Plastic Products Co., Ltd. · 2009 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893822 | Honyee Vinyl Examination Gloves | Honyee Enterprise Co. | 1989 | — |
| 0 (this device) | 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 | — |
| +1 | K983645 | Synthetic Powdered Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998 | — |
| +2 | K011884 | Powdered Synthetic Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001 | — |
| +3 | K032907 | Fuguan (Brand) Powdered Vinyl Patient Examination Gloves | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003 | — |
| +4 | K091662 | Powdered Vinyl Patient Examination Gloves | Zhangjiagang Fengyuan Plastic Products Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K893822 | Honyee Vinyl Examination GlovesSummary page 1…[ the vice: Sunmax Enterprise Shanghai Co., Ltd. Vinyl Patient Examination Gloves - Powdered Predicate Device Information: Honyee Vinyl Patient Examination Gloves, K#893822 Cheer & Merit Vinyl Patient Examination Gloves, K#941809 vice 8C tion: Classified by FDA’s General and Plastic Surgery Device P… | 1989 |
| * | K941809 | Vinyl Patient Examination GlovesSummary page 1…Patient Examination Gloves - Powdered Predicate Device Information: Honyee Vinyl Patient Examination Gloves, K#893822 Cheer & Merit Vinyl Patient Examination Gloves, K#941809 vice 8C tion: Classified by FDA’s General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examinati… | 1995 |
What descends from it? (61)
See all 615 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974151 | Vinyl Patient Examination Gloves (Powdered) | 1997 | 60 |
| K983645 | Synthetic Powdered Vinyl Patient Examination Gloves | 1998 | 51 |
| K992554 | Synthetic Powdered Vinyl Patient Examination Gloves | 2000 | 1 |
| K992797 | Synthetic Powdered Vinyl Patient Examination Gloves | 1999 | 0 |
| K992464 | Synthetic Powdered Vinyl Patient Examination Gloves | 1999 | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K974151 (Shanghai Super Gloves Co., Ltd., 1997) has gone furthest, with 60 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 | — |
What is it indicated for?
A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient’s body, fluids, waste or environment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960746: Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960746
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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