510(k) · Cleared
ClearedNitrile Patient Examination gloves, Powderfree, Blue color
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primus Gloves Pvt Limited · LZA Polymer Patient Examination Glove
Cleared on Apr 14, 2016 as substantially equivalent to K121947 (Northstar Healthcare Holdings, 2012) after a 496-day review. Its family tree reaches back 2 generations to 2007. 3 later devices descend from it.
- Decided
- Apr 14, 2016
- Review
- 496 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K062764 (2007). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK062764 Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)…Kossan Latex Industries (M)Sdn Bhd · 2007
- 1 generation backK121947 Ets Blue Powder-Free Patient Nitrile Examination GlovesNorthstar Healthcare Holdings · 2012
- This deviceK143477 Nitrile Patient Examination gloves, Powderfree, Blue colorPrimus Gloves Pvt Limited · 2016
- Descendant · cites it directly · 0 of its ownK223102 Tegamen Nitrile Examination GlovesM/S Tegamen Safety Products Private Limited · 2023
- Descendant · cites it directly · 0 of its ownK220697 Nitrile Patient Examination Gloves, Powder FreeLalan Rubbers (Pvt), Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK163267 Nitrile Examination GloveBrightway Holdings Sdn. Bhd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K223102Tegamen Nitrile Examination GlovesM/S Tegamen Safety Products Private Limited · 2023 · cites it directly0descendants
- K220697Nitrile Patient Examination Gloves, Powder FreeLalan Rubbers (Pvt), Ltd. · 2022 · cites it directly0descendants
- K163267Nitrile Examination GloveBrightway Holdings Sdn. Bhd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062764 | Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue… | Kossan Latex Industries (M)Sdn Bhd | 2007 | — |
| −1 | K121947 | Ets Blue Powder-Free Patient Nitrile Examination Gloves | Northstar Healthcare Holdings | 2012 | — |
| 0 (this device) | K143477 | Nitrile Patient Examination gloves, Powderfree, Blue color | Primus Gloves Pvt Limited | 2016 | — |
| +1 | K223102 | Tegamen Nitrile Examination Gloves | M/S Tegamen Safety Products Private Limited | 2023 | — |
| +1 | K220697 | Nitrile Patient Examination Gloves, Powder Free | Lalan Rubbers (Pvt), Ltd. | 2022 | — |
| +1 | K163267 | Nitrile Examination Glove | Brightway Holdings Sdn. Bhd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K121947 | Ets Blue Powder-Free Patient Nitrile Examination GlovesSummary page 5…ally marketed predicate device 5.1 Device Name ETS Blue Powderfree Nitrile patient exam glove 5.2 510(k) Number K121947 5.3 Company Northstar Healthcare Holdings, 70 Sir John Rogers… | 2012 |
What descends from it? (3)
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223102 (M/S Tegamen Safety Products Private Limited, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121947.
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?
The Nitrile Patient Examination gloves, Powderfree, Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143477: Nitrile Patient Examination gloves, Powderfree, Blue color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143477
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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