510(k) · Cleared
ClearedPowder Free Vinyl Synthetic Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grand Work Plastic Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Nov 17, 2004 as substantially equivalent to K024026 (Shanghai PM Plastics Enterise Co., Ltd., 2002) after a 35-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Nov 17, 2004
- Review
- 35 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K024026 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK024026 Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera…Shanghai PM Plastics Enterise Co., Ltd. · 2002
- This deviceK042830 Powder Free Vinyl Synthetic Examination GlovesGrand Work Plastic Products Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK092302 Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green…Bettercare Plastic Products Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK060785 Powder Free Vinyl Synthetic Examination Gloves W/Aloe Vera, Green…Ever Light Plastic Products Co., Ltd. · 2006
Most influential descendants
Showing 2 of 2 · See all- K092302Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green ColorBettercare Plastic Products Co., Ltd. · 2010 · cites it directly0descendants
- K060785Powder Free Vinyl Synthetic Examination Gloves W/Aloe Vera, Green ColorEver Light Plastic Products Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024026 | Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green Color | Shanghai PM Plastics Enterise Co., Ltd. | 2002 | — |
| 0 (this device) | K042830 | Powder Free Vinyl Synthetic Examination Gloves | Grand Work Plastic Products Co., Ltd. | 2004 | — |
| +1 | K092302 | Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color | Bettercare Plastic Products Co., Ltd. | 2010 | — |
| +1 | K060785 | Powder Free Vinyl Synthetic Examination Gloves W/Aloe Vera, Green Color | Ever Light Plastic Products Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K024026 | Disposable Powder Free Vinyl Synthetic Exam Gloves with Aloe Vera, Green ColorSummary page 1…cate Device Information: Shanghai PM Plastic s Enterprise Co., Ltd. Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color (K024026) 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class 1,21 CFR 880.6250, Powd… | 2002 |
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?
- Its one ancestor has no recall.
- Of its descendants, K092302 (Bettercare Plastic Products Co., Ltd., 2010) has gone furthest, with 0 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 purposes 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/K042830 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042830: Powder Free Vinyl Synthetic Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042830
Report an extraction error
Are you the manufacturer?
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