510(k) · Cleared
ClearedTrue Advantage Non-Sterile Powder Free Purple Nitrile Examination Glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tillotson Healthcare Corp. · LZA Polymer Patient Examination Glove
Cleared on Oct 19, 2001 after a 42-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Oct 19, 2001
- Review
- 42 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK013016 True Advantage Non-Sterile Powder Free Purple Nitrile Examination…Tillotson Healthcare Corp. · 2001
- Descendant · cites it directly · 2 of its ownK042378 Non-Sterile Powder Free Blue Nitrile Patient Examination GloveShijiazhuang Tillotson Rubber Products Co., Ltd. · 2004
- Descendant · 2 generations on · 1 of its ownK081569 Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam…Dynarex Corporation · 2008
- Descendant · 3 generations on · 0 of its ownK111464 Palm-Pro Powder Free Nitrile Examination GlovesDipped Products (Thailand), Ltd. · 2012
Most influential descendants
Showing 3 of 3 · See all- K042378Non-Sterile Powder Free Blue Nitrile Patient Examination GloveShijiazhuang Tillotson Rubber Products Co., Ltd. · 2004 · cites it directly2descendants
- K081569Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with…Dynarex Corporation · 2008 · 2 generations on1descendant
- K111464Palm-Pro Powder Free Nitrile Examination GlovesDipped Products (Thailand), Ltd. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K081569 | Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for… | Dynarex Corporation | 2008 | — |
| +3 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Pilgram Nitrile Latex, Non-Sterile Examination Glove Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042378 | Non-Sterile Powder Free Blue Nitrile Patient Examination Glove | 2004 | 2 |
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, K042378 (Shijiazhuang Tillotson Rubber Products Co., Ltd., 2004) has gone furthest, with 2 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?
The True Advantage Non-Sterile Powder Free Purple Nitrile Patient Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).
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/K013016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013016: True Advantage Non-Sterile Powder Free Purple Nitrile Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013016
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026