510(k) · Cleared
ClearedNon-Sterile, Powder-Free Nitrile Blue & White Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yty Industry (Manjung) Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Nov 18, 2005 after a 66-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Nov 18, 2005
- Review
- 66 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK052502 Non-Sterile, Powder-Free Nitrile Blue & White Examination GlovesYty Industry (Manjung) Sdn Bhd · 2005
- Descendant · cites it directly · 4 of its ownK143289 Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green…Yty Industry (Manjung) Sdn Bhd · 2015
- Descendant · 2 generations on · 0 of its ownK222721 Violet Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited · 2022
- Descendant · 2 generations on · 0 of its ownK220121 Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and…Aamedix Glove Sdn Bhd · 2022
- Descendant · 2 generations on · 0 of its ownK210388 Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and…Mexpo International, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK210587 Violet Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K143289Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and Violet ColorYty Industry (Manjung) Sdn Bhd · 2015 · cites it directly4descendants
- K222721Violet Nitrile Powder Free Patient Examination Glove, Non SterileSafeskin Retailing (Hk) Limited · 2022 · 2 generations on0descendants
- K220121Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and BlackAamedix Glove Sdn Bhd · 2022 · 2 generations on0descendants
- K210388Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black colorMexpo International, Inc. · 2021 · 2 generations on0descendants
- K210587Violet Nitrile Powder Free Patient Examination Glove, Non SterileOnetexx Sdn Bhd · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052502 | Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves | Yty Industry (Manjung) Sdn Bhd | 2005 | — |
| +1 | K143289 | Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and… | Yty Industry (Manjung) Sdn Bhd | 2015 | — |
| +2 | K222721 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | Safeskin Retailing (Hk) Limited | 2022 | — |
| +2 | K220121 | Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black | Aamedix Glove Sdn Bhd | 2022 | — |
| +2 | K210388 | Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color | Mexpo International, Inc. | 2021 | — |
| +2 | K210587 | Violet Nitrile Powder Free Patient Examination Glove, Non Sterile | Onetexx Sdn Bhd | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | Class I Nitrile Patient Examination Glove 80 LZA, powder free Named without a submission number |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143289 | Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and Violet Color | 2015 | 4 |
| K143055 | Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape, Apple… | 2015 | 0 |
| K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) | 2015 | 0 |
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, K143289 (Yty Industry (Manjung) Sdn Bhd, 2015) has gone furthest, with 4 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.
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 Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves 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 as stated in the FDA summary.
https://510kreport.com/device/K052502 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052502: Non-Sterile, Powder-Free Nitrile Blue & White 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/K052502
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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