510(k) · Cleared
ClearedPowder-Free Vinyl Patient Examination Gloves Colored (White, Yellow)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Manful Light Industrial Products Co., · LYZ Vinyl Patient Examination Glove
Cleared on Jun 14, 2005 as substantially equivalent to K042119 (Shijiazhuang Manful Light Industrial Products Co.,, 2004) after a 41-day review. Its family tree reaches back 1 generation to 2004. 28 later devices descend from it.
- Decided
- Jun 14, 2005
- Review
- 41 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042119 (2004). 28 later devices descend from it, 15 citing it directly.
- Root · 1 generation backK042119 Powder-Free Vinyl Patient Examintion GlovesShijiazhuang Manful Light Industrial Products Co., · 2004
- This deviceK051156 Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow)Shijiazhuang Manful Light Industrial Products Co., · 2005
- Descendant · cites it directly · 7 of its ownK122920 Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)Hebei Leader Plastic Co., Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK110945 Powder-Free Yellow Synthetic Vinyl Patient Examination GlovesZhaoyang Plastic Co., Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK102558 Powder Free Vinyl Patient Examination Gloves, Colored (White)Tangshan Hengda Plastic Products Co., Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK141878 Hongyun Powder-Free Yellow Vinyl Patient Examination GlovesTangshan Hongyun Plastic Products Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK152818 Yongchang Powder-Free Yellow Vinyl Patient Examination GlovesIdeal Plastic Co., Ltd. · 2016
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K122920Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)Hebei Leader Plastic Co., Ltd. · 2012 · cites it directly7descendants
- K110945Powder-Free Yellow Synthetic Vinyl Patient Examination GlovesZhaoyang Plastic Co., Ltd. · 2011 · cites it directly3descendants
- K102558Powder Free Vinyl Patient Examination Gloves, Colored (White)Tangshan Hengda Plastic Products Co., Ltd. · 2010 · cites it directly3descendants
- K141878Hongyun Powder-Free Yellow Vinyl Patient Examination GlovesTangshan Hongyun Plastic Products Co., Ltd. · 2014 · 2 generations on1descendant
- K152818Yongchang Powder-Free Yellow Vinyl Patient Examination GlovesIdeal Plastic Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042119 | Powder-Free Vinyl Patient Examintion Gloves | Shijiazhuang Manful Light Industrial Products Co., | 2004 | — |
| 0 (this device) | K051156 | Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow) | Shijiazhuang Manful Light Industrial Products Co., | 2005 | — |
| +1 | K122920 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) | Hebei Leader Plastic Co., Ltd. | 2012 | — |
| +1 | K110945 | Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves | Zhaoyang Plastic Co., Ltd. | 2011 | — |
| +1 | K102558 | Powder Free Vinyl Patient Examination Gloves, Colored (White) | Tangshan Hengda Plastic Products Co., Ltd. | 2010 | — |
| +2 | K141878 | Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves | Tangshan Hongyun Plastic Products Co., Ltd. | 2014 | — |
| +2 | K152818 | Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves | Ideal Plastic Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 11 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K042119 | Powder-Free Vinyl Patient Examintion GlovesSummary page 1…f the requirements of ASTM standard D 5250-00e4. Predicate device: Powder-Free Vinyl Patient Examination Gloves,. SHIJIAZHUANG MANFUL LIGHT INDUSTRIAL PRODUCTS CO., LTD K042119. [(a)(4)] A description of the device Device Description : powder free vinyl patient examination gloves (white, yellow) that me… | 2004 |
What descends from it? (28)
See all 2815 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122920 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) | 2012 | 7 |
| K110945 | Powder-Free Yellow Synthetic Vinyl Patient Examination Gloves | 2011 | 3 |
| K102558 | Powder Free Vinyl Patient Examination Gloves, Colored (White) | 2010 | 3 |
| K110016 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) | 2011 | 0 |
| K102819 | Powder-Free Vinyl Patient Examination Gloves | 2010 | 0 |
| K102570 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) | 2010 | 0 |
| K102559 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) | 2010 | 0 |
| K102569 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) | 2010 | 0 |
| K101358 | Powder-Free Vinyl Patient Examination Gloves | 2010 | 0 |
| K100057 | Powder-Free Vinyl Patient Examination Gloves, Colored (Yellow) | 2010 | 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?
- Its one ancestor has no recall.
- Of its descendants, K122920 (Hebei Leader Plastic Co., Ltd., 2012) has gone furthest, with 7 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?
Powder free vinyl 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 as stated in the FDA summary.
https://510kreport.com/device/K051156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051156: Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051156
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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