510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · LZA Polymer Patient Examination Glove
Cleared on Jul 8, 2004 after a 98-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Jul 8, 2004
- Review
- 98 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK040841 Powder Free Nitrile Examination Gloves (Tested for Use with…Medline Industries, Inc. · 2004
- Descendant · cites it directly · 6 of its ownK071072 Shanghai China Star Corp. Powder Free Blue Nitrile Patient…Shanghai China Star Corp · 2007
- Descendant · cites it directly · 5 of its ownK090336 Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient…Sunmax Enterprise Shanghai Co., Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK102593 Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK101870 Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd. · 2010
- Descendant · 3 generations on · 0 of its ownK211667 Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071072Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination GloveShanghai China Star Corp · 2007 · cites it directly6descendants
- K090336Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination Glove Tested…Sunmax Enterprise Shanghai Co., Ltd. · 2009 · cites it directly5descendants
- K102593Synthetic, Powder-Free Nitrile ExaminationZibo Yinghao Medical Products Co., Ltd. · 2010 · 2 generations on1descendant
- K101870Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination GloveSunmax Vietnam Co., Ltd. · 2010 · 2 generations on1descendant
- K211667Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)Changzhou Universal Medical Equipment Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040841 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) | Medline Industries, Inc. | 2004 | — |
| +1 | K071072 | Shanghai China Star Corp. Powder Free Blue Nitrile Patient Examination Glove | Shanghai China Star Corp | 2007 | — |
| +1 | K090336 | Sunmax Enterprise Shanghai CO. Powder Free Blue Nitrile Patient Examination… | Sunmax Enterprise Shanghai Co., Ltd. | 2009 | — |
| +2 | K102593 | Synthetic, Powder-Free Nitrile Examination | Zibo Yinghao Medical Products Co., Ltd. | 2010 | — |
| +2 | K101870 | Sunmax Vietnam CO. LTD Powder Free White Nitrile Examination Glove | Sunmax Vietnam Co., Ltd. | 2010 | — |
| +3 | K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | Changzhou Universal Medical Equipment Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
2 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, K071072 (Shanghai China Star Corp, 2007) has gone furthest, with 6 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?
Medline Powder-Free Blue Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040841 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040841: Powder Free Nitrile Examination Gloves (Tested 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/K040841
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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