510(k) · Cleared
ClearedNon-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
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 Jan 16, 2015 as substantially equivalent to K052502 (Yty Industry (Manjung) Sdn Bhd, 2005) after a 154-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Jan 16, 2015
- Review
- 154 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052502 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK052502 Non-Sterile, Powder-Free Nitrile Blue & White Examination GlovesYty Industry (Manjung) Sdn Bhd · 2005
- This deviceK142283 Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and…Yty Industry (Manjung) Sdn Bhd · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052502 | Non-Sterile, Powder-Free Nitrile Blue & White Examination Gloves | Yty Industry (Manjung) Sdn Bhd | 2005 | — |
| 0 (this device) | K142283 | Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White… | Yty Industry (Manjung) Sdn Bhd | 2015 | — |
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 |
|---|---|---|---|
| * | K052502 | Non-Sterile, Powder-Free Nitrile Blue & White Examination GlovesSummary page 4…listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Gloves for Medical Application. Predicate 510(K) number for this application is K052502. Sec 1 Sum Page 1 of 6 5.0 Description of The Device Non-Steri… | 2005 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K052502.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Non Sterile, Powder Free Nitrile Examination Gloves [(8603F (AD) Blue Color, 8611F (M) Blue Color, 8603F (Y4) Blue Color, 8613F Blue Color, 8603F (H) Blue Color, 8612F (C) Blue Color, 8604T Black Color and 8617F White Color] is a non-sterile disposable device intended for medical purpose 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/K142283 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142283: Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142283
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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