510(k) · Cleared
ClearedVinyl Examination Glove, Powder-Free, Clear (Non-Colored)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Feb 19, 2009 as substantially equivalent to K070149 (Wuxi Shenzhou Plastic Products Co., Ltd., 2007) and 1 other predicate after a 76-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Feb 19, 2009
- Review
- 76 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000071 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK000071 Synthetic Powder Free (White) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 2000
- 2 generations backK032908 Fuguan (Brand) Powder-Free Vinyl Patient Examination GlovesShijiazhuang Fuguan Plastic Products Co., Ltd. · 2003
- 1 generation backK070149 Powder-Free Vinyl Patient Examination GlovesWuxi Shenzhou Plastic Products Co., Ltd. · 2007
- This deviceK083600 Vinyl Examination Glove, Powder-Free, Clear (Non-Colored)Quantum Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000071 | Synthetic Powder Free (White) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 2000 | — |
| −2 | K032908 | Fuguan (Brand) Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Fuguan Plastic Products Co., Ltd. | 2003 | — |
| −1 | K070149 | Powder-Free Vinyl Patient Examination Gloves | Wuxi Shenzhou Plastic Products Co., Ltd. | 2007 | — |
| 0 (this device) | K083600 | Vinyl Examination Glove, Powder-Free, Clear (Non-Colored) | Quantum Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K070149 | Powder-Free Vinyl Patient Examination GlovesSummary page 1…Examination Gloves for Medical Application" Predicate Device A) K070149 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, MA… | 2007 |
| * | K073193 | Powder-Free Vinyl Patient Examination GlovesSummary page 1…BY: Wuxi SHENZHOU PLASTIC PRODUCTS CO., LTD. B) K073193 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES… | 2007 |
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 9 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K070149.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 vinyl Examination glove, clear (non-colored) 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/K083600 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083600: Vinyl Examination Glove, Powder-Free, Clear (Non-Colored).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083600
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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