510(k) · Cleared
ClearedSynmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zibo Huiying Medical Products, Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Feb 5, 2016 as substantially equivalent to K051662 (Grand Work Plastic Products Co., Ltd., 2005) after a 112-day review. Its family tree reaches back 1 generation to 2005. 10 later devices descend from it.
- Decided
- Feb 5, 2016
- Review
- 112 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051662 (2005). 10 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK051662 Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color)Grand Work Plastic Products Co., Ltd. · 2005
- This deviceK153028 Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueZibo Huiying Medical Products, Co., Ltd. · 2016
- Descendant · cites it directly · 1 of its ownK211262 Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Healthcare Products Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK213634 Vinyl/Nitrile Blend Exam GloveDezhou Hengchang Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK212436 NBR Synthetic Nitrile Examination GlovesShandong Langtai International Trade Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK212899 Disposable Vinyl/Nitrile Blend Medical Examination GlovesBytech (Dongtai) Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK212488 Synthetic Nitrile Examination GlovesShandong Hongxin Chemicals Co., Ltd. · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K211262Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Healthcare Products Co., Ltd. · 2021 · cites it directly1descendant
- K213634Vinyl/Nitrile Blend Exam GloveDezhou Hengchang Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
- K212436NBR Synthetic Nitrile Examination GlovesShandong Langtai International Trade Co., Ltd. · 2021 · cites it directly0descendants
- K212899Disposable Vinyl/Nitrile Blend Medical Examination GlovesBytech (Dongtai) Co., Ltd. · 2021 · 2 generations on0descendants
- K212488Synthetic Nitrile Examination GlovesShandong Hongxin Chemicals Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051662 | Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color) | Grand Work Plastic Products Co., Ltd. | 2005 | — |
| 0 (this device) | K153028 | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue | Zibo Huiying Medical Products, Co., Ltd. | 2016 | — |
| +1 | K211262 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | Tangshan Hongyun Healthcare Products Co., Ltd. | 2021 | — |
| +1 | K213634 | Vinyl/Nitrile Blend Exam Glove | Dezhou Hengchang Medical Technology Co., Ltd. | 2022 | — |
| +1 | K212436 | NBR Synthetic Nitrile Examination Gloves | Shandong Langtai International Trade Co., Ltd. | 2021 | — |
| +2 | K212899 | Disposable Vinyl/Nitrile Blend Medical Examination Gloves | Bytech (Dongtai) Co., Ltd. | 2021 | — |
| +1 | K212488 | Synthetic Nitrile Examination Gloves | Shandong Hongxin Chemicals Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 9 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K051662 | Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color)Summary page 4…e . Common Name: Patient Examination Gloves Predicate Device Information: Grand Work Plastic Products Co., Ltd. Vinyl Nitrile Co-Polymer Powder Free Exam Blue Gloves (K051662) Device Description: Classified by FDA’s General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Viny… | 2005 |
What descends from it? (10)
9 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211262 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | 2021 | 1 |
| K213634 | Vinyl/Nitrile Blend Exam Glove | 2022 | 0 |
| K212436 | NBR Synthetic Nitrile Examination Gloves | 2021 | 0 |
| K212488 | Synthetic Nitrile Examination Gloves | 2021 | 0 |
| K212002 | Synthetic Vinyl Examination Gloves | 2021 | 0 |
| K211516 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | 2021 | 0 |
| K211354 | Disposable Synthetic Vinyl Nitrile Examination Glove | 2021 | 0 |
| K211045 | Synthetic Vinyl Examination Gloves | 2021 | 0 |
| K210520 | Disposable Synthetic Examination Gloves | 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?
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?
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner’s hands or fingers to prevent contamination between patient and examiner.
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/K153028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153028: Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153028
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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