510(k) · Cleared
ClearedNon-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ug Global Resources Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Jul 18, 2017 as substantially equivalent to K112012 (Ug Healthcare (Usa), Inc., 2012) after a 313-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jul 18, 2017
- Review
- 313 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000689 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK000689 Uniglove Nitrile Powder-Free Examination GlovesN.S. Uni-Gloves Sdn. Bhd. · 2000
- 1 generation backK112012 Non-Sterile, Powder-Free Blue, Nitrile Examination GlovesUg Healthcare (Usa), Inc. · 2012
- This deviceK162510 Non-Sterile, Powder-Free, Nitrile Examination Gloves, BlueUg Global Resources Sdn. Bhd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000689 | Uniglove Nitrile Powder-Free Examination Gloves | N.S. Uni-Gloves Sdn. Bhd. | 2000 | — |
| −1 | K112012 | Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves | Ug Healthcare (Usa), Inc. | 2012 | — |
| 0 (this device) | K162510 | Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue | Ug Global Resources 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 |
|---|---|---|---|
| * | K112012 | Non-Sterile, Powder-Free Blue, Nitrile Examination GlovesSummary page 4…ient Examination Glove (per 21 CFR 880.6250) Class 1: Powder-Free Nitrile examination glove LZA that meets all of the requirements of ASTM 6319-10. Predicative Devices (K112012):Non-Sterile, Powder-Free, Blue, Nitrile Examination Gloves Device Description: The subject device of this submission is a Nitri… | 2012 |
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 3 companies; a new generation was cleared every 11.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K112012.
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?
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162510: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162510
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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