510(k) · Cleared
ClearedDynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynarex Corporation · LZA Polymer Patient Examination Glove
Cleared on Sep 12, 2008 as substantially equivalent to K042378 (Shijiazhuang Tillotson Rubber Products Co., Ltd., 2004) after a 100-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Sep 12, 2008
- Review
- 100 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013016 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK013016 True Advantage Non-Sterile Powder Free Purple Nitrile Examination…Tillotson Healthcare Corp. · 2001
- 1 generation backK042378 Non-Sterile Powder Free Blue Nitrile Patient Examination GloveShijiazhuang Tillotson Rubber Products Co., Ltd. · 2004
- This deviceK081569 Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam…Dynarex Corporation · 2008
- Descendant · cites it directly · 0 of its ownK111464 Palm-Pro Powder Free Nitrile Examination GlovesDipped Products (Thailand), Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K111464Palm-Pro Powder Free Nitrile Examination GlovesDipped Products (Thailand), Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013016 | True Advantage Non-Sterile Powder Free Purple Nitrile Examination Glove | Tillotson Healthcare Corp. | 2001 | — |
| −1 | K042378 | Non-Sterile Powder Free Blue Nitrile Patient Examination Glove | Shijiazhuang Tillotson Rubber Products Co., Ltd. | 2004 | — |
| 0 (this device) | K081569 | Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for… | Dynarex Corporation | 2008 | — |
| +1 | K111464 | Palm-Pro Powder Free Nitrile Examination Gloves | Dipped Products (Thailand), Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K042378 | Non-Sterile Powder Free Blue Nitrile Patient Examination GloveSummary page 1…, Ltd., China Non-Sterile Powder-Free Blue Nitrile Examination Glove, (K042378). Device Description/ Comparison Classified by FDA's General and Plastic Surgery Device panel… | 2004 |
| * | — | Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy… Named without a submission number |
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 |
|---|---|---|---|
| K111464 | Palm-Pro Powder Free Nitrile Examination Gloves | 2012 | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111464 (Dipped Products (Thailand), Ltd., 2012) 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. 2008, 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 patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
These gloves are tested for use with Chemotherapy Drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081569: Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081569
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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