510(k) · Cleared
ClearedSynthetic Powder Free (Yellow) Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Great Eagle Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Oct 6, 1999 after a 42-day review. The FDA summary names no predicate by number. 16 later devices descend from it.
- Decided
- Oct 6, 1999
- Review
- 42 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 11 citing it directly.
- This deviceK992861 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Great Eagle Plastic Products Co., Ltd. · 1999
- Descendant · cites it directly · 3 of its ownK092301 Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue…Bettercare Plastic Products Co., Ltd. · 2009
- Descendant · 2 generations on · 2 of its ownK101135 Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue…Hongze Plastic Technology Co., Ltd. · 2010
- Descendant · 3 generations on · 1 of its ownK142570 Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue…Ever Light Plastic Products Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK053523 Powder Free Sterile Vinyl Glove (Clear and Yellow)Shijiazhuang Hongxiang Plastics Products Co., Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK011882 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Eversharp Plastic Products Co., Ltd. · 2001
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K092301Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink)Bettercare Plastic Products Co., Ltd. · 2009 · cites it directly3descendants
- K101135Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue, Pink)Hongze Plastic Technology Co., Ltd. · 2010 · 2 generations on2descendants
- K142570Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink )Ever Light Plastic Products Co., Ltd. · 2014 · 3 generations on1descendant
- K053523Powder Free Sterile Vinyl Glove (Clear and Yellow)Shijiazhuang Hongxiang Plastics Products Co., Ltd. · 2006 · cites it directly1descendant
- K011882Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Eversharp Plastic Products Co., Ltd. · 2001 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992861 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Great Eagle Plastic Products Co., Ltd. | 1999 | — |
| +1 | K092301 | Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) | Bettercare Plastic Products Co., Ltd. | 2009 | — |
| +2 | K101135 | Powder Free Vinyl Patient Examination Gloves (Yellow, White,Blue, Pink) | Hongze Plastic Technology Co., Ltd. | 2010 | — |
| +3 | K142570 | Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) | Ever Light Plastic Products Co., Ltd. | 2014 | — |
| +1 | K053523 | Powder Free Sterile Vinyl Glove (Clear and Yellow) | Shijiazhuang Hongxiang Plastics Products Co., Ltd. | 2006 | — |
| +1 | K011882 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Eversharp Plastic Products Co., Ltd. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 1611 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092301 | Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink) | 2009 | 3 |
| K053523 | Powder Free Sterile Vinyl Glove (Clear and Yellow) | 2006 | 1 |
| K011882 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | 2001 | 1 |
| K101132 | Powder Free Vinyl Patient Examination Gloves, (Blue, White, Pink) | 2010 | 0 |
| K093797 | Powder Free Vinyl Patient Examination Gloves (Yellow, White) | 2010 | 0 |
| K082029 | Synthetic Powder Free (Pink) Vinyl Patient Examination Glove | 2008 | 0 |
| K070038 | Powder Free Vinyl Patient Examination Glove, Yellow | 2007 | 0 |
| K070188 | Powder Free Vinyl Patient Examination Glove, Yellow | 2007 | 0 |
| K070044 | Powder Free (Yellow) Vinyl Patient Examination | 2007 | 0 |
| K060786 | Synthetic (Yellow) Vinyl Patient Examination Glove-Powder Free | 2006 | 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?
- Of its descendants, K092301 (Bettercare Plastic Products Co., Ltd., 2009) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 a disposable device intended for medical purposes 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/K992861 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992861: Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992861
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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