510(k) · Cleared
ClearedSynthetic, Powder-Free Nitrile Examination
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zibo Yinghao Medical Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Dec 20, 2010 as substantially equivalent to K090336 (Sunmax Enterprise Shanghai Co., Ltd., 2009) after a 102-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Dec 20, 2010
- Review
- 102 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022765 (2002). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK022765 Nitrile Powder-Free Examination GlovesAllegiance Healthcare Corp. · 2002
- 2 generations backK071072 Shanghai China Star Corp. Powder Free Blue Nitrile Patient…Shanghai China Star Corp · 2007
- 1 generation backK090336 Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient…Sunmax Enterprise Shanghai Co., Ltd. · 2009
- This deviceK102593 Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK211667 Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022765 | Nitrile Powder-Free Examination Gloves | Allegiance Healthcare Corp. | 2002 | — |
| −2 | K071072 | Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove | Shanghai China Star Corp | 2007 | — |
| −1 | K090336 | Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination… | Sunmax Enterprise Shanghai Co., Ltd. | 2009 | — |
| 0 (this device) | K102593 | Synthetic, Powder-Free Nitrile Examination | Zibo Yinghao Medical Products Co., Ltd. | 2010 | — |
| +1 | K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | Changzhou Universal Medical Equipment Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K090336 | Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested…Summary page 1…mination Gloves — Powder Free, Blue Color Predicate Device Informaton: Sunmax Enterprise Shanghai Co., Ltd. Synthetic Nitrile Patient Examination Gloves — Powder Free (K090336) Device Description: Classified by FDA’s General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitr… | 2009 |
| * | — | Tangshan Zhonghong Pulin Group Co., Ltd. Powder-Free Nitrile Patient Examination Gloves Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | 2021 | 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 4 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K211667 (Changzhou Universal Medical Equipment Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090336.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
A patient examination glove is a disposable device intended for medical purposes that is
worn upon the examiner’s hands or finger to prevent contamination between patient and
examiner (21CFR 880.6250)
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/K102593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102593: Synthetic, Powder-Free Nitrile Examination.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102593
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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