510(k) · Cleared
ClearedMicro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ansell Healthcare Products, LLC · LZA Polymer Patient Examination Glove
Cleared on Dec 29, 2017 as substantially equivalent to K123469 (Wear Safe (Malaysia) Sdn Bhd - Facility II, 2013) after a 200-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Dec 29, 2017
- Review
- 200 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062764 (2007). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK062764 Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)…Kossan Latex Industries (M)Sdn Bhd · 2007
- 2 generations backK111772 Powder Free Nitrile Patient Examination Glove, Blue Colored and…Kossan Latex Industries (M)Sdn Bhd · 2011
- 1 generation backK123469 Powder Free Nitrile Patient Examination Glove, Blue and White…Wear Safe (Malaysia) Sdn Bhd - Facility II · 2013
- This deviceK171737 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination GlovesAnsell Healthcare Products, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062764 | Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue… | Kossan Latex Industries (M)Sdn Bhd | 2007 | — |
| −2 | K111772 | Powder Free Nitrile Patient Examination Glove, Blue Colored and White… | Kossan Latex Industries (M)Sdn Bhd | 2011 | — |
| −1 | K123469 | Powder Free Nitrile Patient Examination Glove, Blue and White Colored… | Wear Safe (Malaysia) Sdn Bhd - Facility II | 2013 | — |
| 0 (this device) | K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | Ansell Healthcare Products, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K123469 | Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-SterileSummary page 4…ation Gloves, Blue Colored and white (Non- colored), Non-sterile, without Polymer (Chlorinated) 510(k) Number: K123469 Device Class: Class I Product Code: LZA (Nitrile) Device Name:… | 2013 |
| † | K051793 | Encore Sterile Powder-Free Latex Surgical Glove with Proprietary Coating (Containing… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K123469.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves are intended for medical purposes that are worn on the examiners hands to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171737: Micro Touch Denta Glove Nitrile Hydrasoft Patient 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/K171737
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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