510(k) · Cleared
ClearedVinyl Examination Glove (Clear, Non-Colored)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhicheng Trading Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jun 13, 2018 as substantially equivalent to K163168 (Hebei Hongtai Plastic Products Company Limited, 2017) after a 72-day review. Its family tree reaches back 4 generations to 2009. 9 later devices descend from it.
- Decided
- Jun 13, 2018
- Review
- 72 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K091431 (2009). 9 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK091431 Powder-Free, Yellow Vinyl Patient Examination GlovesZibo Yusheng Plastic Products Co., Ltd. · 2009
- 3 generations backK142508 Powder Free Yellow Vinyl Patient Examination GlovesZibo Huaqi Trading Co., Ltd. · 2014
- 2 generations backK150224 Blue Vinyl Gloves Powder FreeZibo Sanying Trade Co., Ltd. · 2015
- 1 generation backK163168 Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue)…Hebei Hongtai Plastic Products Company Limited · 2017
- This deviceK180861 Vinyl Examination Glove (Clear, Non-Colored)Zhicheng Trading Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK223008 Disposable Vinyl Examination GlovesJiangxi Handspro Products Solutions Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK220469 Disposable Vinyl Examination GloveChifeng Huawei Medical Science&Technology Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK213006 Vinyl Examination GlovesTaian Hengchang Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK252505 Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK241252 Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K223008Disposable Vinyl Examination GlovesJiangxi Handspro Products Solutions Co., Ltd. · 2022 · cites it directly1descendant
- K220469Disposable Vinyl Examination GloveChifeng Huawei Medical Science&Technology Co., Ltd. · 2022 · cites it directly1descendant
- K213006Vinyl Examination GlovesTaian Hengchang Medical Technology Co., Ltd. · 2021 · cites it directly1descendant
- K252505Powder-Free Vinyl Exam Gloves, clearBasic Medical Technology, Inc. · 2025 · 2 generations on0descendants
- K241252Disposable Vinyl Examination GlovesAnqing Pukang Medical Technology Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K091431 | Powder-Free, Yellow Vinyl Patient Examination Gloves | Zibo Yusheng Plastic Products Co., Ltd. | 2009 | — |
| −3 | K142508 | Powder Free Yellow Vinyl Patient Examination Gloves | Zibo Huaqi Trading Co., Ltd. | 2014 | — |
| −2 | K150224 | Blue Vinyl Gloves Powder Free | Zibo Sanying Trade Co., Ltd. | 2015 | — |
| −1 | K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl… | Hebei Hongtai Plastic Products Company Limited | 2017 | — |
| 0 (this device) | K180861 | Vinyl Examination Glove (Clear, Non-Colored) | Zhicheng Trading Co., Ltd. | 2018 | — |
| +1 | K223008 | Disposable Vinyl Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | 2022 | — |
| +1 | K220469 | Disposable Vinyl Examination Glove | Chifeng Huawei Medical Science&Technology Co., Ltd. | 2022 | — |
| +1 | K213006 | Vinyl Examination Gloves | Taian Hengchang Medical Technology Co., Ltd. | 2021 | — |
| +2 | K252505 | Powder-Free Vinyl Exam Gloves, clear | Basic Medical Technology, Inc. | 2025 | — |
| +2 | K241252 | Disposable Vinyl Examination Gloves | Anqing Pukang Medical Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination…Summary page 5…e standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile. 6. Identification of Predicate Device(s) Predicate Device K163168 Vinyl Patient Examination Gloves (White, Blue, Yellow) Hebei Hongtai Plastic Products Company Limited… | 2017 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223008 | Disposable Vinyl Examination Gloves | 2022 | 1 |
| K220469 | Disposable Vinyl Examination Glove | 2022 | 1 |
| K213006 | Vinyl Examination Gloves | 2021 | 1 |
| K222442 | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) | 2022 | 0 |
| K220055 | Disposable, vinyl examination gloves, Yellow | 2022 | 0 |
| K213625 | Vinyl Examination Gloves | 2022 | 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 9 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K223008 (Jiangxi Handspro Products Solutions Co., Ltd., 2022) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K163168.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Examination Glove (Clear, Non-Colored) is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180861: Vinyl Examination Glove (Clear, Non-Colored).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180861
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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