510(k) · Cleared
ClearedNon-Sterile, Powder-Free Blue, Nitrile Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ug Healthcare (Usa), Inc. · LZA Polymer Patient Examination Glove
Cleared on Mar 21, 2012 as substantially equivalent to K000689 (N.S. Uni-Gloves Sdn. Bhd., 2000) after a 252-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Mar 21, 2012
- Review
- 252 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000689 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000689 Uniglove Nitrile Powder-Free Examination GlovesN.S. Uni-Gloves Sdn. Bhd. · 2000
- This deviceK112012 Non-Sterile, Powder-Free Blue, Nitrile Examination GlovesUg Healthcare (Usa), Inc. · 2012
- Descendant · cites it directly · 0 of its ownK232319 Black Pearl Nitrile Examination GloveUg Global Resources Sdn. Bhd. · 2024
- Descendant · cites it directly · 0 of its ownK162510 Non-Sterile, Powder-Free, Nitrile Examination Gloves, BlueUg Global Resources Sdn. Bhd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000689 | Uniglove Nitrile Powder-Free Examination Gloves | N.S. Uni-Gloves Sdn. Bhd. | 2000 | — |
| 0 (this device) | K112012 | Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves | Ug Healthcare (Usa), Inc. | 2012 | — |
| +1 | K232319 | Black Pearl Nitrile Examination Glove | Ug Global Resources Sdn. Bhd. | 2024 | — |
| +1 | K162510 | Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue | Ug Global Resources Sdn. Bhd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K000689 | Uniglove Nitrile Powder-Free Examination GlovesSummary page 2…re and after aging, and the Protein Labeling Claim Level at c5Oug/g. This product is as safe, as effective, and performs as well or better than the legally marketed 510 #K000689. It has been supported by results of Biocompatibility Tests, Residual Powder Content tests, Physical Property Tests and the lOO0m… | 2000 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K232319 (Ug Global Resources Sdn. Bhd., 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 examiners hand to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112012: Non-Sterile, Powder-Free Blue, Nitrile Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112012
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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