510(k) · Cleared
ClearedPowder-Free Non-Sterile Vinyl Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lpl (Hui Zhou) Glove Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Jul 20, 2011 as substantially equivalent to K100978 (Jiangsu Sunshine Plastic Products, Co., Ltd., 2010) after a 42-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Jul 20, 2011
- Review
- 42 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100978 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK100978 Powder Free Non-Sterile Vinyl Examination GloveJiangsu Sunshine Plastic Products, Co., Ltd. · 2010
- This deviceK111598 Powder-Free Non-Sterile Vinyl Examination GloveLpl (Hui Zhou) Glove Co., Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100978 | Powder Free Non-Sterile Vinyl Examination Glove | Jiangsu Sunshine Plastic Products, Co., Ltd. | 2010 | — |
| 0 (this device) | K111598 | Powder-Free Non-Sterile Vinyl Examination Glove | Lpl (Hui Zhou) Glove Co., Ltd. | 2011 | — |
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 |
|---|---|---|---|
| * | K100978 | Powder Free Non-Sterile Vinyl Examination GloveSummary page 1…LYZ l(a)l3)l An identification of the legally marketed device to which your firm is claiming substantial equivalence. Predicate Device Information: (1) K100978, "Powder-Free Non-Sterile Vinyl Examination Glove", manufactured by "Jiangsu Sunshine Plastic Products, Co., Ltd"… | 2010 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K100978.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The powder free vinyl patient examination glove (non-sterile) is a disposable device intended for medical purposes that is worn on the examiner's band or finger to prevent contamination between patient and examiner. It is sold as non-sterile.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111598: Powder-Free Non-Sterile Vinyl 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/K111598
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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