510(k) · Cleared
ClearedVinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hebei Hongtai Plastic Products Company Limited · LYZ Vinyl Patient Examination Glove
Cleared on Feb 23, 2017 as substantially equivalent to K150224 (Zibo Sanying Trade Co., Ltd., 2015) after a 101-day review. Its family tree reaches back 3 generations to 2009. 30 later devices descend from it.
- Decided
- Feb 23, 2017
- Review
- 101 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K091431 (2009). 30 later devices descend from it, 17 citing it directly.
- Root · 3 generations backK091431 Powder-Free, Yellow Vinyl Patient Examination GlovesZibo Yusheng Plastic Products Co., Ltd. · 2009
- 2 generations backK142508 Powder Free Yellow Vinyl Patient Examination GlovesZibo Huaqi Trading Co., Ltd. · 2014
- 1 generation backK150224 Blue Vinyl Gloves Powder FreeZibo Sanying Trade Co., Ltd. · 2015
- This deviceK163168 Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue)…Hebei Hongtai Plastic Products Company Limited · 2017
- Descendant · cites it directly · 9 of its ownK180861 Vinyl Examination Glove (Clear, Non-Colored)Zhicheng Trading Co., Ltd. · 2018
- Descendant · cites it directly · 4 of its ownK180849 Vinyl Examination Glove (Clear, Non-Colored)Huifu Trading Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK182043 Single-use medical poly (vinyl chloride) examination glove (Clear…Hebei Titans Hongsen Medical Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK223008 Disposable Vinyl Examination GlovesJiangxi Handspro Products Solutions Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK220469 Disposable Vinyl Examination GloveChifeng Huawei Medical Science&Technology Co., Ltd. · 2022
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K180861Vinyl Examination Glove (Clear, Non-Colored)Zhicheng Trading Co., Ltd. · 2018 · cites it directly9descendants
- K180849Vinyl Examination Glove (Clear, Non-Colored)Huifu Trading Co., Ltd. · 2018 · cites it directly4descendants
- K182043Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)Hebei Titans Hongsen Medical Technology Co., Ltd. · 2018 · cites it directly2descendants
- K223008Disposable Vinyl Examination GlovesJiangxi Handspro Products Solutions Co., Ltd. · 2022 · 2 generations on1descendant
- K220469Disposable Vinyl Examination GloveChifeng Huawei Medical Science&Technology Co., Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K091431 | Powder-Free, Yellow Vinyl Patient Examination Gloves | Zibo Yusheng Plastic Products Co., Ltd. | 2009 | — |
| −2 | K142508 | Powder Free Yellow Vinyl Patient Examination Gloves | Zibo Huaqi Trading Co., Ltd. | 2014 | — |
| −1 | K150224 | Blue Vinyl Gloves Powder Free | Zibo Sanying Trade Co., Ltd. | 2015 | — |
| 0 (this device) | K163168 | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl… | Hebei Hongtai Plastic Products Company Limited | 2017 | — |
| +1 | K180861 | Vinyl Examination Glove (Clear, Non-Colored) | Zhicheng Trading Co., Ltd. | 2018 | — |
| +1 | K180849 | Vinyl Examination Glove (Clear, Non-Colored) | Huifu Trading Co., Ltd. | 2018 | — |
| +1 | K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2018 | — |
| +2 | K223008 | Disposable Vinyl Examination Gloves | Jiangxi Handspro Products Solutions Co., Ltd. | 2022 | — |
| +2 | K220469 | Disposable Vinyl Examination Glove | Chifeng Huawei Medical Science&Technology Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 6 | 0 |
| 2020 | 2 | 0 |
| 2021 | 13 | 0 |
| 2022 | 6 | 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 |
|---|---|---|---|
| * | K150224 | Blue Vinyl Gloves Powder FreeSummary page 5…, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile. 6. Identification of Predicate Device(s) Predicate Device K150224 Blue Vinyl Examination Gloves Powder Free ZIBO SANYING TRADE CO., LTD 7. Non-Clinical Test Conclusion Non c… | 2015 |
What descends from it? (30)
See all 3017 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180861 | Vinyl Examination Glove (Clear, Non-Colored) | 2018 | 9 |
| K180849 | Vinyl Examination Glove (Clear, Non-Colored) | 2018 | 4 |
| K182043 | Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) | 2018 | 2 |
| K210799 | Powder Free Vinyl Patient Examination Gloves | 2021 | 1 |
| K211698 | Vinyl Examination Gloves (Yellow) | 2021 | 0 |
| K211904 | Vinyl Glove | 2021 | 0 |
| K211239 | Vinyl Patient Examination Gloves | 2021 | 0 |
| K211336 | Disposable Vinyl Examination Glove | 2021 | 0 |
| K210522 | Disposable Vinyl Examination Gloves | 2021 | 0 |
| K203666 | Vinyl Examination Gloves (Yellow) | 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 3 ancestors has a recall.
- Of its descendants, K180861 (Zhicheng Trading Co., Ltd., 2018) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K150224.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Gloves (White, Blue, or Yellow) 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/K163168 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163168: Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163168
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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