510(k) · Cleared
ClearedPowder Free Blue Nitrile Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vietglove Corporation · LZA Polymer Patient Examination Glove
Cleared on Apr 1, 2016 after a 109-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Apr 1, 2016
- Review
- 109 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK153562 Powder Free Blue Nitrile Examination GloveVietglove Corporation · 2016
- Descendant · cites it directly · 2 of its ownK210369 Powder Free Nitrile Examination GlovePastel Glove Sdn Bhd · 2021
- Descendant · cites it directly · 1 of its ownK201428 Powder Free Black Nitrile Examination GloveVietglove Corporation · 2021
- Descendant · cites it directly · 1 of its ownK210375 Powder Free Blue Nitrile Examination GloveDuramitt Sdn Bhd · 2021
- Descendant · 2 generations on · 0 of its ownK221378 Nitrile Powder Free Blue Patient Examination Gloves, Non-SterileTec Gloves Industry (M) Sdn.Bhd. · 2022
- Descendant · 2 generations on · 0 of its ownK212751 Powder Free Nitrile Examination GloveDainam Glove Joint Stock Company · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210369Powder Free Nitrile Examination GlovePastel Glove Sdn Bhd · 2021 · cites it directly2descendants
- K201428Powder Free Black Nitrile Examination GloveVietglove Corporation · 2021 · cites it directly1descendant
- K210375Powder Free Blue Nitrile Examination GloveDuramitt Sdn Bhd · 2021 · cites it directly1descendant
- K221378Nitrile Powder Free Blue Patient Examination Gloves, Non-SterileTec Gloves Industry (M) Sdn.Bhd. · 2022 · 2 generations on0descendants
- K212751Powder Free Nitrile Examination GloveDainam Glove Joint Stock Company · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K153562 | Powder Free Blue Nitrile Examination Glove | Vietglove Corporation | 2016 | — |
| +1 | K210369 | Powder Free Nitrile Examination Glove | Pastel Glove Sdn Bhd | 2021 | — |
| +1 | K201428 | Powder Free Black Nitrile Examination Glove | Vietglove Corporation | 2021 | — |
| +1 | K210375 | Powder Free Blue Nitrile Examination Glove | Duramitt Sdn Bhd | 2021 | — |
| +2 | K221378 | Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile | Tec Gloves Industry (M) Sdn.Bhd. | 2022 | — |
| +2 | K212751 | Powder Free Nitrile Examination Glove | Dainam Glove Joint Stock Company | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 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?
- Of its descendants, K210369 (Pastel Glove Sdn Bhd, 2021) has gone furthest, with 2 descendants 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. 2016, 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?
A patient examination glove 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
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153562: Powder Free Blue Nitrile 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/K153562
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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