510(k) · Cleared
ClearedVinyl Patient Examination Gloves (Powdered)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Super Gloves Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Dec 18, 1997 as substantially equivalent to K960746 (Sunmax Enterprise Shanghai Co., Ltd., 1996) and 1 other predicate after a 44-day review. Its family tree reaches back 2 generations to 1989. 60 later devices descend from it.
- Decided
- Dec 18, 1997
- Review
- 44 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K893822 (1989). 3 ancestors in all. 60 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK893822 Honyee Vinyl Examination GlovesHonyee Enterprise Co. · 1989
- 1 generation backK960746 Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. GlovesSunmax Enterprise Shanghai Co., Ltd. · 1996
- This deviceK974151 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
- Descendant · 2 generations on · 5 of its ownK992862 Synthetic Powdered (Yellow) Vinyl Patient Examination GlovesShijiazhuang Great Vision Plastic Products Co., LT · 1999
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- 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
- K992862Synthetic Powdered (Yellow) Vinyl Patient Examination GlovesShijiazhuang Great Vision Plastic Products Co., LT · 1999 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K893822 | Honyee Vinyl Examination Gloves | Honyee Enterprise Co. | 1989 | — |
| −1 | K960746 | Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves | Sunmax Enterprise Shanghai Co., Ltd. | 1996 | — |
| 0 (this device) | 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 | — |
| +2 | K992862 | Synthetic Powdered (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Great Vision Plastic Products Co., LT | 1999 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K960746 | Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. GlovesSummary page 1…ghai Super Gloves Co., Ltd. Vinyl Patient Examination Gloves - Powdered 3. Predicate Device Information: Sunmax Enterprise Shanghai Vinyl Patient Examination Gloves, K#960746 Cheer & Merit Vinyl Patient Examination Gloves, K#941809 4. Device Description: Classified by FDA's General and Plastic Surgery… | 1996 |
| * | K941809 | Vinyl Patient Examination GlovesSummary page 1…ves - Powdered 3. Predicate Device Information: Sunmax Enterprise Shanghai Vinyl Patient Examination Gloves, K#960746 Cheer & Merit Vinyl Patient Examination Gloves, K#941809 4. Device Description: Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient… | 1995 |
What descends from it? (60)
See all 606 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983645 | Synthetic Powdered Vinyl Patient Examination Gloves | 1998 | 51 |
| K984461 | Pre-Powder Vinyl Patient Examination Gloves | 1999 | 2 |
| K992554 | Synthetic Powdered Vinyl Patient Examination Gloves | 2000 | 1 |
| K992797 | Synthetic Powdered Vinyl Patient Examination Gloves | 1999 | 0 |
| K992271 | Pre-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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K983645 (Shijiazhuang Great Eagle Plastic Products Co., Ltd., 1998) has gone furthest, with 51 descendants of its own.
- 4 other devices also cite its predicate K960746.
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 patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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/K974151 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974151: Vinyl Patient Examination Gloves (Powdered).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974151
Report an extraction error
Are you the manufacturer?
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