510(k) · Cleared
ClearedPowder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bettercare Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Oct 22, 2009 as substantially equivalent to K992861 (Shijiazhuang Great Eagle Plastic Products Co., Ltd., 1999) after an 85-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Oct 22, 2009
- Review
- 85 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992861 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992861 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1999
- This deviceK092301 Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue…Bettercare Plastic Products Co., Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK101135 Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue…Hongze Plastic Technology Co., Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK142570 Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue…Ever Light Plastic Products Co., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK180260 Powder Free Vinyl Patient Examination Gloves (Yellow, White)Shanxi Hongjin Plastic Technology Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K101135Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue, Pink)Hongze Plastic Technology Co., Ltd. · 2010 · cites it directly2descendants
- K142570Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )Ever Light Plastic Products Co., Ltd. · 2014 · 2 generations on1descendant
- K180260Powder Free Vinyl Patient Examination Gloves (Yellow, White)Shanxi Hongjin Plastic Technology Co., Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992861 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1999 | — |
| 0 (this device) | K092301 | Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) | Bettercare Plastic Products Co., Ltd. | 2009 | — |
| +1 | K101135 | Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue, Pink) | Hongze Plastic Technology Co., Ltd. | 2010 | — |
| +2 | K142570 | Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) | Ever Light Plastic Products Co., Ltd. | 2014 | — |
| +3 | K180260 | Powder Free Vinyl Patient Examination Gloves (Yellow, White) | Shanxi Hongjin Plastic Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K992861 | Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesSummary page 1…low, white, blue, pink) 3. Predicate Device Information: Shijiazhuang Great Eagle Plastic Products Co., Ltd Powder-Free (Yellow) Vinyl Patient Examination Gloves (K992861) 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Power Fr… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101135 | Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue, Pink) | 2010 | 2 |
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. 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?
A patient examination glove is disposable device intended for medical purpose 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/K092301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092301: Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092301
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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