510(k) · Cleared
ClearedDisposable Vinyl Nitrile Synthetic Gloves Powder Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tangshan Hongyun Healthcare Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jul 24, 2021 as substantially equivalent to K153028 (Zibo Huiying Medical Products, Co., Ltd., 2016) after an 89-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Jul 24, 2021
- Review
- 89 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051662 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK051662 Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color)Grand Work Plastic Products Co., Ltd. · 2005
- 1 generation backK153028 Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueZibo Huiying Medical Products, Co., Ltd. · 2016
- This deviceK211262 Disposable Vinyl Nitrile Synthetic Gloves Powder FreeTangshan Hongyun Healthcare Products Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK212899 Disposable Vinyl/Nitrile Blend Medical Examination GlovesBytech (Dongtai) Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212899Disposable Vinyl/Nitrile Blend Medical Examination GlovesBytech (Dongtai) Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051662 | Vinyl Nitrile CO-Polymer Powder Free Exam Gloves (Blue Color) | Grand Work Plastic Products Co., Ltd. | 2005 | — |
| −1 | K153028 | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue | Zibo Huiying Medical Products, Co., Ltd. | 2016 | — |
| 0 (this device) | K211262 | Disposable Vinyl Nitrile Synthetic Gloves Powder Free | Tangshan Hongyun Healthcare Products Co., Ltd. | 2021 | — |
| +1 | K212899 | Disposable Vinyl/Nitrile Blend Medical Examination Gloves | Bytech (Dongtai) Co., Ltd. | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K153028 | Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, BlueSummary page 4…icate Device Information Manufacturer: Zibo Huiying Medical Products, Co. Ltd. Device: Synmax Synthetic Patient Examination Vinyl Gloves,Powder Free,Blue 510(k) number: K153028 5.0 Indication for Use 1 of page 5 Synthetic Examination Gloves… | 2016 |
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 |
|---|---|---|---|
| K212899 | Disposable Vinyl/Nitrile Blend Medical 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K212899 (Bytech (Dongtai) Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K153028.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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
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/K211262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211262: Disposable Vinyl Nitrile Synthetic Gloves Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211262
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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