510(k) · Cleared
ClearedVinyl CO-Polmer Free Examination Gloves, Blue 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 Oct 21, 2009 as substantially equivalent to K061562 (Grand Work Plastic Products Co., Ltd., 2006) after an 84-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 21, 2009
- Review
- 84 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001834 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001834 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Hongxiang Plastics Products Co;, Ltd. · 2000
- 2 generations backK042247 Synthetic (Blue) Vinyl Patient Examination Gloves - Powder FreeShijiazhuang Hongxiang Plastics Products Co., Ltd. · 2004
- 1 generation backK061562 Vinyl CO-Polymer Powder Free Examination Gloves, Blue ColorGrand Work Plastic Products Co., Ltd. · 2006
- This deviceK092294 Vinyl CO-Polmer Free Examination Gloves, Blue ColorBettercare Plastic Products Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001834 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co;, Ltd. | 2000 | — |
| −2 | K042247 | Synthetic (Blue) Vinyl Patient Examination Gloves - Powder Free | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2004 | — |
| −1 | K061562 | Vinyl CO-Polymer Powder Free Examination Gloves, Blue Color | Grand Work Plastic Products Co., Ltd. | 2006 | — |
| 0 (this device) | K092294 | Vinyl CO-Polmer Free Examination Gloves, Blue Color | Bettercare Plastic Products Co., Ltd. | 2009 | — |
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 |
|---|---|---|---|
| * | K061562 | Vinyl CO-Polymer Powder Free Examination Gloves, Blue ColorSummary page 1…Free Examination Gloves, Blue Color 3. Predicate Device Information: Grand Work Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K061562) 4. Device Description; Classified by FDA’s General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Vinyl Co-Poly… | 2006 |
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 9 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K061562.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092294 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092294: Vinyl CO-Polmer Free Examination Gloves, Blue Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092294
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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