510(k) · Cleared
ClearedPowder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color
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 May 5, 2010 as substantially equivalent to K042830 (Grand Work Plastic Products Co., Ltd., 2004) after a 280-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- May 5, 2010
- Review
- 280 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K024026 (2002). No later device cites it as a predicate yet.
- Root · 2 generations backK024026 Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera…Shanghai PM Plastics Enterise Co., Ltd. · 2002
- 1 generation backK042830 Powder Free Vinyl Synthetic Examination GlovesGrand Work Plastic Products Co., Ltd. · 2004
- This deviceK092302 Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green…Bettercare Plastic Products Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K024026 | Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color | Shanghai PM Plastics Enterise Co., Ltd. | 2002 | — |
| −1 | K042830 | Powder Free Vinyl Synthetic Examination Gloves | Grand Work Plastic Products Co., Ltd. | 2004 | — |
| 0 (this device) | K092302 | Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color | Bettercare Plastic Products Co., Ltd. | 2010 | — |
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 |
|---|---|---|---|
| * | K042830 | Powder Free Vinyl Synthetic Examination GlovesSummary page 1…, Green Color 3. Predicate Device Information: Grand Work Plastic Products Co., Ltd Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color (K042830) 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CER 880.6250, Powder F… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K042830.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 a 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/K092302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092302: Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092302
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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