510(k) · Cleared
ClearedNon Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aamedix Glove Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Apr 11, 2022 as substantially equivalent to K143289 (Yty Industry (Manjung) Sdn Bhd, 2015) after an 83-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Apr 11, 2022
- Review
- 83 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052502 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK052502 Non-Sterile, Powder-Free Nitrile Blue & White Examination GlovesYty Industry (Manjung) Sdn Bhd · 2005
- 1 generation backK143289 Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green…Yty Industry (Manjung) Sdn Bhd · 2015
- This deviceK220121 Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and…Aamedix Glove Sdn Bhd · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K220121 | Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black | Aamedix Glove Sdn Bhd | 2022 | — |
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 |
|---|---|---|---|
| * | K143289 | Non-Sterile, Power Free Nitrile Examination Gloves-Orange, Green, Blue and Violet ColorSummary page 5…tion Gloves Classification : Class I Product Code : LZA Regulation Number : 21 CFR 880.6250 4. Predicate Device 510K Number : K143289- YTY Industry (Manjung) Sdn. Bhd. Device Name : Non Sterile, Powder Free Nitrile Examination Gloves -… | 2015 |
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 17 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K143289.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 powder-free 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 as stated in the FDA summary.
https://510kreport.com/device/K220121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220121: Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220121
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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