510(k) · Cleared
ClearedNitrile Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brightway Holdings Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Mar 24, 2017 as substantially equivalent to K143477 (Primus Gloves Pvt Limited, 2016) after a 123-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Mar 24, 2017
- Review
- 123 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062764 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK062764 Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)…Kossan Latex Industries (M)Sdn Bhd · 2007
- 2 generations backK121947 Ets Blue Powder-Free Patient Nitrile Examination GlovesNorthstar Healthcare Holdings · 2012
- 1 generation backK143477 Nitrile Patient Examination gloves, Powderfree, Blue colorPrimus Gloves Pvt Limited · 2016
- This deviceK163267 Nitrile Examination GloveBrightway Holdings Sdn. Bhd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062764 | Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue… | Kossan Latex Industries (M)Sdn Bhd | 2007 | — |
| −2 | K121947 | Ets Blue Powder-Free Patient Nitrile Examination Gloves | Northstar Healthcare Holdings | 2012 | — |
| −1 | K143477 | Nitrile Patient Examination gloves, Powderfree, Blue color | Primus Gloves Pvt Limited | 2016 | — |
| 0 (this device) | K163267 | Nitrile Examination Glove | Brightway Holdings Sdn. Bhd. | 2017 | — |
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 |
|---|---|---|---|
| * | K143477 | Nitrile Patient Examination gloves, Powderfree, Blue colorSummary page 5…ets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250. Predicate Device: Legally Marketed Devices to which Substantial Equivalence is claimed ; K143477- Nitrile Patient Examination Gloves, Powderfree, Blue Color 5. Device Description : The subject device in this 510(k) Noti… | 2016 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K143477.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE (BLUE) is a disposable device intended for medical purpose to be worn on the examiners hand or finger to prevent contamination between the patient and the 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/K163267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163267: Nitrile Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163267
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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