510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves White Colored Non-Sterile
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 Aug 19, 2011 as substantially equivalent to K093696 (Central Medicare Sdn Bhd, 2010) after a 240-day review. Its family tree reaches back 1 generation to 2010. 2 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 240 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093696 (2010). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK093696 SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803Central Medicare Sdn Bhd · 2010
- This deviceK103734 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 · cites it directly · 0 of its ownK120184 Powder Free Nitrile Examination Glove, Blue Colored, Black Colored…Encompass Medical Supplies Inc Limited · 2012
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 | K093696 | SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803 | Central Medicare Sdn Bhd | 2010 | — |
| 0 (this device) | K103734 | Powder Free Nitrile Examination Gloves White Colored Non-Sterile | Central Medicare Sdn Bhd | 2011 | — |
| +1 | K113440 | High Five | Central Medicare Sdn Bhd | 2012 | — |
| +1 | 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 |
|---|---|---|
| 2012 | 2 | 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 |
|---|---|---|---|
| * | K093696 | SR Glove, NU Glove, Highstress Model 801, Model 802, Model 803Summary page 1…andard Specification for Nitrile Examination Gloves for Medical Application. Predicate device: Blue Nitrile Examination Gloves, Powder Free (K093696) 9.0 Description of Device: The Powder Free Nitrile Examination Glove White Colored Class I patient ex… | 2010 |
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?
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103734 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103734: Powder Free Nitrile Examination Gloves White Colored Non-Sterile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103734
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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