510(k) · Cleared
ClearedXinfu Powder-Free Yellow Vinyl Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xinfu Medical Products Co., Ltd. · LYZ Vinyl Patient Examination Glove
Cleared on Mar 1, 2016 as substantially equivalent to K122920 (Hebei Leader Plastic Co., Ltd., 2012) after a 162-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Mar 1, 2016
- Review
- 162 days
- Class
- Class I
- Product code
- LYZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042119 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK042119 Powder-Free Vinyl Patient Examintion GlovesShijiazhuang Manful Light Industrial Products Co., · 2004
- 2 generations backK051156 Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow)Shijiazhuang Manful Light Industrial Products Co., · 2005
- 1 generation backK122920 Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)Hebei Leader Plastic Co., Ltd. · 2012
- This deviceK152719 Xinfu Powder-Free Yellow Vinyl Patient Examination GlovesXinfu Medical Products Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042119 | Powder-Free Vinyl Patient Examintion Gloves | Shijiazhuang Manful Light Industrial Products Co., | 2004 | — |
| −2 | K051156 | Powder-Free Vinyl Patient Examination Gloves Colored (White, Yellow) | Shijiazhuang Manful Light Industrial Products Co., | 2005 | — |
| −1 | K122920 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow) | Hebei Leader Plastic Co., Ltd. | 2012 | — |
| 0 (this device) | K152719 | Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves | Xinfu Medical Products Co., Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K122920 | Powder Free Vinyl Patient Examination Gloves, Colored (Yellow)Summary page 4…ements of ASTM standard D 5250-06 (Reaffirmation 2011). Predicate device: Powder Free Vinyl Patient Examination Gloves. Colored (Yellow), Hebei Leader Plastic Co., Ltd. K122920. Section C Page 1 [(a)(4)] A descriptio… | 2012 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K122920.
How does its category compare?
All LYZ devicesLYZ Vinyl Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Powder-Free Yellow Vinyl Patient Examination Gloves is a non-sterile 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/K152719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152719: Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152719
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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