510(k) · Cleared
ClearedSenicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxxim Medical, Inc. · LZA Polymer Patient Examination Glove
Cleared on May 17, 2001 after a 28-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 17, 2001
- Review
- 28 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK011198 Senicare Advantix Powder Free Polyurethane Medical Examination…Maxxim Medical, Inc. · 2001
- Descendant · cites it directly · 1 of its ownK031384 Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane…Yty Industry (Manjung) Sdn Bhd · 2003
- Descendant · 2 generations on · 0 of its ownK213168 Medical Examination GlovesShandong Huiwosheng Health Technology Co.,Ltd · 2022
- Descendant · cites it directly · 0 of its ownK022095 Duraclean with Lycra Powder Free Polyurethane Medical Examination…Wilshire Technologies · 2002
- Descendant · cites it directly · 0 of its ownK021452 Sterile Sensicare Advantix Powder Free Polyurethane Medical/Dental…Maxxim Medical · 2002
Most influential descendants
Showing 4 of 4 · See all- K031384Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane White Color…Yty Industry (Manjung) Sdn Bhd · 2003 · cites it directly1descendant
- K213168Medical Examination GlovesShandong Huiwosheng Health Technology Co.,Ltd · 2022 · 2 generations on0descendants
- K022095Duraclean with Lycra Powder Free Polyurethane Medical Examination GloveWilshire Technologies · 2002 · cites it directly0descendants
- K021452Sterile Sensicare Advantix Powder Free Polyurethane Medical/Dental Examination GloveMaxxim Medical · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011198 | Senicare Advantix Powder Free Polyurethane Medical Examination Glove… | Maxxim Medical, Inc. | 2001 | — |
| +1 | K031384 | Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane White Color… | Yty Industry (Manjung) Sdn Bhd | 2003 | — |
| +2 | K213168 | Medical Examination Gloves | Shandong Huiwosheng Health Technology Co.,Ltd | 2022 | — |
| +1 | K022095 | Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove | Wilshire Technologies | 2002 | — |
| +1 | K021452 | Sterile Sensicare Advantix Powder Free Polyurethane Medical/Dental Examination… | Maxxim Medical | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
3 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, K031384 (Yty Industry (Manjung) Sdn Bhd, 2003) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K011198 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011198: Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix Powder Free Polyurethane Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011198
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026