510(k) · Cleared
ClearedSR Glove, NU Glove, Highstress Model 801, Model 802, Model 803
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Central Medicare Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Feb 12, 2010 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Feb 12, 2010
- Review
- 74 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK093696 SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803Central Medicare Sdn Bhd · 2010
- Descendant · cites it directly · 2 of its ownK103734 Powder Free Nitrile Examination Gloves White Colored Non-SterileCentral Medicare Sdn Bhd · 2011
- Descendant · cites it directly · 0 of its ownK113440 High FiveCentral Medicare Sdn Bhd · 2012
- Descendant · 2 generations on · 0 of its ownK120184 Powder Free Nitrile Examination Glove, Blue Colored, Black Colored…Encompass Medical Supplies Inc Limited · 2012
Most influential descendants
Showing 3 of 3 · See all- K103734Powder Free Nitrile Examination Gloves White Colored Non-SterileCentral Medicare Sdn Bhd · 2011 · cites it directly2descendants
- K113440High FiveCentral Medicare Sdn Bhd · 2012 · cites it directly0descendants
- K120184Powder Free Nitrile Examination Glove, Blue Colored, Black Colored and White ColoredEncompass Medical Supplies Inc Limited · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093696 | SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803 | Central Medicare Sdn Bhd | 2010 | — |
| +1 | K103734 | Powder Free Nitrile Examination Gloves White Colored Non-Sterile | Central Medicare Sdn Bhd | 2011 | — |
| +1 | K113440 | High Five | Central Medicare Sdn Bhd | 2012 | — |
| +2 | K120184 | Powder Free Nitrile Examination Glove, Blue Colored, Black Colored and White… | Encompass Medical Supplies Inc Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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?
- Of its descendants, K103734 (Central Medicare Sdn Bhd, 2011) has gone furthest, with 2 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. 2010, 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?
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093696 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093696: SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093696
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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