510(k) · Cleared
ClearedSynthetic (Blue) Vinyl Patient Examination Gloves - Powder Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shijiazhuang Hongxiang Plastics Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Sep 2, 2004 as substantially equivalent to K001834 (Shijiazhuang Hongxiang Plastics Products Co;, Ltd., 2000) after a 14-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Sep 2, 2004
- Review
- 14 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001834 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001834 Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShijiazhuang Hongxiang Plastics Products Co;, Ltd. · 2000
- This deviceK042247 Synthetic (Blue) Vinyl Patient Examination Gloves - Powder FreeShijiazhuang Hongxiang Plastics Products Co., Ltd. · 2004
- Descendant · cites it directly · 4 of its ownK061562 Vinyl CO-Polymer Powder Free Examination Gloves, Blue ColorGrand Work Plastic Products Co., Ltd. · 2006
- Descendant · 2 generations on · 1 of its ownK142409 Vinyl Co-Polymer Powder Free Examination GlovesGrand Work Plastic Products Co., Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK220240 Vinyl Co-Polymer Powder-free Examination Gloves, BlackGrand Work Plastic Products Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK092294 Vinyl CO-Polmer Free Examination Gloves, Blue ColorBettercare Plastic Products Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK070852 Vinyl CO-Polymer Powder Free Examination Gloves, Blue ColorShijiazhang Hongxiang Plastic Products Co., Ltd. · 2007
Most influential descendants
Showing 5 of 5 · See all- K061562Vinyl CO-Polymer Powder Free Examination Gloves, Blue ColorGrand Work Plastic Products Co., Ltd. · 2006 · cites it directly4descendants
- K142409Vinyl Co-Polymer Powder Free Examination GlovesGrand Work Plastic Products Co., Ltd. · 2014 · 2 generations on1descendant
- K220240Vinyl Co-Polymer Powder-free Examination Gloves, BlackGrand Work Plastic Products Co., Ltd. · 2022 · 3 generations on0descendants
- K092294Vinyl CO-Polmer Free Examination Gloves, Blue ColorBettercare Plastic Products Co., Ltd. · 2009 · 2 generations on0descendants
- K070852Vinyl CO-Polymer Powder Free Examination Gloves, Blue ColorShijiazhang Hongxiang Plastic Products Co., Ltd. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001834 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | Shijiazhuang Hongxiang Plastics Products Co;, Ltd. | 2000 | — |
| 0 (this device) | 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 | — |
| +2 | K142409 | Vinyl Co-Polymer Powder Free Examination Gloves | Grand Work Plastic Products Co., Ltd. | 2014 | — |
| +3 | K220240 | Vinyl Co-Polymer Powder-free Examination Gloves, Black | Grand Work Plastic Products Co., Ltd. | 2022 | — |
| +2 | K092294 | Vinyl CO-Polmer Free Examination Gloves, Blue Color | Bettercare Plastic Products Co., Ltd. | 2009 | — |
| +2 | K070852 | Vinyl CO-Polymer Powder Free Examination Gloves, Blue Color | Shijiazhang Hongxiang Plastic Products Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K001834 | Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061562 | Vinyl CO-Polymer Powder Free Examination Gloves, Blue Color | 2006 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K061562 (Grand Work Plastic Products Co., Ltd., 2006) has gone furthest, with 4 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 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/K042247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042247: Synthetic (Blue) Vinyl Patient Examination Gloves - Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042247
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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