510(k) · Cleared
ClearedVinyl patient examination glove, Powder Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xingyuan Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jan 26, 2016 as substantially equivalent to K150224 (Zibo Sanying Trade Co., Ltd., 2015) after an 85-day review. Its family tree reaches back 3 generations to 2009.
- Decided
- Jan 26, 2016
- Review
- 85 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K091431 (2009). No later device cites it as a predicate yet.
- Root · 3 generations backK091431 Powder-Free, Yellow Vinyl Patient Examination GlovesZibo Yusheng Plastic Products Co., Ltd. · 2009
- 2 generations backK142508 Powder Free Yellow Vinyl Patient Examination GlovesZibo Huaqi Trading Co., Ltd. · 2014
- 1 generation backK150224 Blue Vinyl Gloves Powder FreeZibo Sanying Trade Co., Ltd. · 2015
- This deviceK153159 Vinyl patient examination glove, Powder FreeXingyuan Plastic Products Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K091431 | Powder-Free, Yellow Vinyl Patient Examination Gloves | Zibo Yusheng Plastic Products Co., Ltd. | 2009 | — |
| −2 | K142508 | Powder Free Yellow Vinyl Patient Examination Gloves | Zibo Huaqi Trading Co., Ltd. | 2014 | — |
| −1 | K150224 | Blue Vinyl Gloves Powder Free | Zibo Sanying Trade Co., Ltd. | 2015 | — |
| 0 (this device) | K153159 | Vinyl patient examination glove, Powder Free | Xingyuan Plastic Products Co., Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K150224 | Blue Vinyl Gloves Powder FreeSummary page 5…s that is worn on the examiner’s hands or finger to prevent contamination between patient and examiner. 5. Predicate Device Identification 510(k) Number: k150224 Product Name: BLUE VINYL GLOVES POWDER FREE Manufacturer: ZIBO SANYING TRADE CO., LTD 6. Device Description… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K150224.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Vinyl patient examination glove, Powder Free, is a disposable device intended for medical purposes that is worn on
the examiner’s hands or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153159 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153159: Vinyl patient examination glove, Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153159
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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