510(k) · Cleared
ClearedPowder-Free Yellow Synthetic Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhaoyang Plastic Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Sep 13, 2011 as substantially equivalent to K051156 (Shijiazhuang Manful Light Industrial Products Co.,, 2005) after a 162-day review. Its family tree reaches back 2 generations to 2004. 3 later devices descend from it.
- Decided
- Sep 13, 2011
- Review
- 162 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042119 (2004). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK042119 Powder-Free Vinyl Patient Examintion GlovesShijiazhuang Manful Light Industrial Products Co., · 2004
- 1 generation backK051156 Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow)Shijiazhuang Manful Light Industrial Products Co., · 2005
- This deviceK110945 Powder-Free Yellow Synthetic Vinyl Patient Examination GlovesZhaoyang Plastic Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK131340 Powder Free Yellow Synthetic Vinyl Patient Examination GlovesMade Plastic Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK131341 Powder Free Yellow Synthetic Vinyl Patient Examination GlovesShijiazhuang Winful Plastic Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK131344 Powder Free Yellow Synthetic Vinyl Patient Examination GlovesShijiazhuang Wally Plastics Co., Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K131340Powder Free Yellow Synthetic Vinyl Patient Examination GlovesMade Plastic Co., Ltd. · 2014 · cites it directly0descendants
- K131341Powder Free Yellow Synthetic Vinyl Patient Examination GlovesShijiazhuang Winful Plastic Co., Ltd. · 2014 · cites it directly0descendants
- K131344Powder Free Yellow Synthetic Vinyl Patient Examination GlovesShijiazhuang Wally Plastics Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042119 | Powder-Free Vinyl Patient Examintion Gloves | Shijiazhuang Manful Light Industrial Products Co., | 2004 | — |
| −1 | K051156 | Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow) | Shijiazhuang Manful Light Industrial Products Co., | 2005 | — |
| 0 (this device) | K110945 | Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves | Zhaoyang Plastic Co., Ltd. | 2011 | — |
| +1 | K131340 | Powder Free Yellow Synthetic Vinyl Patient Examination Gloves | Made Plastic Co., Ltd. | 2014 | — |
| +1 | K131341 | Powder Free Yellow Synthetic Vinyl Patient Examination Gloves | Shijiazhuang Winful Plastic Co., Ltd. | 2014 | — |
| +1 | K131344 | Powder Free Yellow Synthetic Vinyl Patient Examination Gloves | Shijiazhuang Wally Plastics Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K051156 | Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow)Summary page 1…tient Examination Gloves(White, Yellow), SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD. KO051156. t (a)(4)I A description of the device Device Description: Powder-free yellow synthetic vinyl… | 2005 |
What descends from it? (3)
3 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131340 (Made Plastic Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 14 other devices also cite its predicate K051156.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
Powder-free yellow synthetic vinyl patient examination gloves 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 as stated in the FDA summary.
https://510kreport.com/device/K110945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110945: Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110945
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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