510(k) · Cleared
ClearedDisposable Medical Examination Nitrile Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Raxwell Industrial, LLC · LZA Polymer Patient Examination Glove
Cleared on Aug 8, 2023 as substantially equivalent to K213121 (Jiangsu Cureguard Glove Co., Ltd., 2022) after a 33-day review. Its family tree reaches back 2 generations to 2018. 3 later devices descend from it.
- Decided
- Aug 8, 2023
- Review
- 33 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K171422 (2018). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK171422 Disposable Powder Free Nitrile Examination Glove, White/ Blue/…Ever Global (Vietnam) Enterprise Corp · 2018
- 1 generation backK213121 Disposable Nitrile Examination GloveJiangsu Cureguard Glove Co., Ltd. · 2022
- This deviceK232008 Disposable Medical Examination Nitrile GlovesRaxwell Industrial, LLC · 2023
- Descendant · cites it directly · 1 of its ownK240361 Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder…Hebei Titans Hongsen Medical Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK253824 Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company Limited · 2026
- Descendant · 2 generations on · 0 of its ownK260806 Nitrile Disposable Examination GlovesVista Industries,, LLC · 2026
Most influential descendants
Showing 3 of 3 · See all- K240361Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL); Powder Free Pink Nitrile…Hebei Titans Hongsen Medical Technology Co., Ltd. · 2024 · cites it directly1descendant
- K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company Limited · 2026 · cites it directly0descendants
- K260806Nitrile Disposable Examination GlovesVista Industries,, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K171422 | Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color | Ever Global (Vietnam) Enterprise Corp | 2018 | — |
| −1 | K213121 | Disposable Nitrile Examination Glove | Jiangsu Cureguard Glove Co., Ltd. | 2022 | — |
| 0 (this device) | 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 | — |
| +1 | K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | 2026 | — |
| +2 | K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 2 | 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 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 |
|---|---|---|---|
| * | K213121 | Disposable Nitrile Examination GloveSummary page 4…Regulation Number 21 CFR 880.6250 Regulation Number LZA Review Panel: General Hospital 5 PREDICATE DEVICE Predicate Device 510k number: K213121 Predicate Device Manufacturer: Jiangsu Cureguard Glove Co., Ltd. 1 / 5 K232008 ===… | 2022 |
What descends from it? (3)
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240361 (Hebei Titans Hongsen Medical Technology Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Disposable Medical Examination Nitrile Gloves is a disposable device intended for medical purposes that is worn on the examiner’s hands to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232008 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232008: Disposable Medical Examination Nitrile Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232008
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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