510(k) · Cleared
ClearedPowder Free Examination Glove
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 K983207 (Shijiazhuang Great Eagle Plastic Products Co., Ltd., 1998) after an 84-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Oct 21, 2009
- Review
- 84 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942042 (1994). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942042 Powder Free Vinyl Patient Examination GlovesCheer & Merit Co., Ltd. · 1994
- 1 generation backK983207 Synthetic Powder-Free Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1998
- This deviceK092296 Powder Free Examination GloveBettercare Plastic Products Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK102093 Powder Free Vinyl Patient Examination GlovesShijiazhuang Great Vision Plastic Products Co., LT · 2010
- Descendant · cites it directly · 0 of its ownK101137 Powder Free Vinyl Patient Examination GloveHongze Plastic Technology Co., Ltd. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942042 | Powder Free Vinyl Patient Examination Gloves | Cheer & Merit Co., Ltd. | 1994 | — |
| −1 | K983207 | Synthetic Powder-Free Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1998 | — |
| 0 (this device) | K092296 | Powder Free Examination Glove | Bettercare Plastic Products Co., Ltd. | 2009 | — |
| +1 | K102093 | Powder Free Vinyl Patient Examination Gloves | Shijiazhuang Great Vision Plastic Products Co., LT | 2010 | — |
| +1 | K101137 | Powder Free Vinyl Patient Examination Glove | Hongze Plastic Technology Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K983207 | Synthetic Powder-Free Vinyl Patient Examination GlovesSummary page 1…y! Patient Examination Glove . Predicate Device Information: Shijiazhuang Great Eagle Plastic Products Co., Ltd Synthetic Powder-Free Vinyl Patient Examination Gloves (K983207) 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class |, 21 CFR 880.6250, Power Free Vi… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102093 (Shijiazhuang Great Vision Plastic Products Co., LT, 2010) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K983207.
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/K092296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092296: Powder Free Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092296
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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