510(k) · Cleared
ClearedNitrile Disposable Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vista Industries,, LLC · LZA Polymer Patient Examination Glove
Cleared on Jun 3, 2026 as substantially equivalent to K240361 (Hebei Titans Hongsen Medical Technology Co., Ltd., 2024) after an 83-day review. Its family tree reaches back 4 generations to 2018.
- Decided
- Jun 3, 2026
- Review
- 83 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K171422 (2018). No later device cites it as a predicate yet.
- Root · 4 generations backK171422 Disposable Powder Free Nitrile Examination Glove, White/ Blue/…Ever Global (Vietnam) Enterprise Corp · 2018
- 3 generations backK213121 Disposable Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd. · 2022
- 2 generations backK232008 Disposable Medical Examination Nitrile GlovesRaxwell Industrial, LLC · 2023
- 1 generation backK240361 Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder…Hebei Titans Hongsen Medical Technology Co., Ltd. · 2024
- This deviceK260806 Nitrile Disposable Examination GlovesVista Industries,, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Ever Global (Vietnam) Enterprise Corp | 2018 | — |
| −3 | K213121 | Disposable Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | 2022 | — |
| −2 | K232008 | Disposable Medical Examination Nitrile Gloves | Raxwell Industrial, LLC | 2023 | — |
| −1 | K240361 | Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink… | Hebei Titans Hongsen Medical Technology Co., Ltd. | 2024 | — |
| 0 (this device) | K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026 | — |
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 LZA? 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 LZA device
- #1 K192333 Blue Nitrile Examination Gloves Powder Freescore 71.0 · 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 |
|---|---|---|---|
| * | K240361 | Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile…Summary page 5…gulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA 3. Predicate Device 510(k) Number: K240361 Product Name: Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile Examination Gloves (XS/S/M/L/X… | 2024 |
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 8 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 2025
MAUDE reports naming product code LZA, 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 | 21 | 95 | 0 | 7 |
| 2008 | 18 | 97 | 0 | 2 |
| 2009 | 28 | 112 | 0 | 12 |
| 2010 | 31 | 97 | 0 | 12 |
| 2011 | 26 | 122 | 0 | 9 |
| 2012 | 33 | 110 | 0 | 11 |
| 2013 | 20 | 130 | 0 | 10 |
| 2014 | 27 | 197 | 0 | 8 |
| 2015 | 20 | 112 | 1 | 12 |
| 2016 | 30 | 171 | 1 | 25 |
| 2017 | 44 | 124 | 0 | 4 |
| 2018 | 22 | 178 | 0 | 3 |
| 2019 | 25 | 212 | 0 | 21 |
| 2020 | 30 | 101 | 0 | 4 |
| 2021 | 139 | 111 | 0 | 20 |
| 2022 | 146 | 111 | 0 | 19 |
| 2023 | 62 | 92 | 0 | 24 |
| 2024 | 30 | 89 | 0 | 76 |
| 2025 | 24 | 110 | 0 | 73 |
| 2026 | 15 | 103 | 3 | — |
What is it indicated for?
Nitrile disposable examination gloves are 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 as stated in the FDA summary.
https://510kreport.com/device/K260806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260806: Nitrile Disposable 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/K260806
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026