510(k) · Cleared
ClearedPolyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxxim Medical · LZA Polymer Patient Examination Glove
Cleared on Jul 30, 1999 as substantially equivalent to K965095 (Ansell Edmont Industrial, Inc., 1997) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jul 30, 1999
- Review
- 81 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944182 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK944182 Powder Free Medical GloveBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- This deviceK991615 Polyurethane Powder Free Dental Examination Glove, Polyurethane…Maxxim Medical · 1999
- Descendant · cites it directly · 0 of its ownK022095 Duraclean with Lycra Powder Free Polyurethane Medical Examination…Wilshire Technologies · 2002
Most influential descendants
Showing 1 of 1 · See all- K022095Duraclean with Lycra Powder Free Polyurethane Medical Examination GloveWilshire Technologies · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944182 | Powder Free Medical Glove | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| 0 (this device) | K991615 | Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free… | Maxxim Medical | 1999 | — |
| +1 | K022095 | Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove | Wilshire Technologies | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K965095 | Nitra-Touch Powder-Free Nitrile Medical Examination GloveSummary page 1…ially equivalent to the Nitra-Touch™ Nitrile Powder Free Medical Examination gloves and SensiCare™ Powder Free Vinyl Medical Examination gloves, originally cleared under K965095 and K944182 respectively. The results of the safety, efficacy and performance testing of the Polyurethane Powder Free Examination… | 1997 |
| * | K944182 | Powder Free Medical GloveSummary page 1…lent to the Nitra-Touch™ Nitrile Powder Free Medical Examination gloves and SensiCare™ Powder Free Vinyl Medical Examination gloves, originally cleared under K965095 and K944182 respectively. The results of the safety, efficacy and performance testing of the Polyurethane Powder Free Examination Gloves are… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022095 | Duraclean with Lycra Powder Free Polyurethane Medical Examination Glove | 2002 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K022095 (Wilshire Technologies, 2002) 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.
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 patient examination glove is a dispoéable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991615 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991615: Polyurethane Powder Free Dental Examination Glove, Polyurethane Powder Free Medical Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991615
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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