510(k) · Cleared
ClearedPowder Free Vinyl Patient Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifestyle Safty Products (Hui Zhou) Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Sep 13, 2012 as substantially equivalent to K100978 (Jiangsu Sunshine Plastic Products, Co., Ltd., 2010) after a 358-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Sep 13, 2012
- Review
- 358 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 deviceK112741 Powder Free Vinyl Patient Examination GloveLifestyle Safty Products (Hui Zhou) Co., Ltd. · 2012
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) | K112741 | Powder Free Vinyl Patient Examination Glove | Lifestyle Safty Products (Hui Zhou) Co., Ltd. | 2012 | — |
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 lUa)(3)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. 2012, 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 hand 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/K112741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112741: Powder Free Vinyl Patient 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/K112741
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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