510(k) · Cleared
ClearedPowder-Free Nitrie Examination Gloves, Orange
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shen Wei (Usa), Inc. · LZA Polymer Patient Examination Glove
Cleared on Aug 17, 2012 as substantially equivalent to K090194 (Shen Wei (Usa), Inc., 2009) after a 147-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.
- Decided
- Aug 17, 2012
- Review
- 147 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090194 (2009). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK090194 Powder- Free Nitrile Examination Gloves, Black ColorShen Wei (Usa), Inc. · 2009
- This deviceK120890 Powder-Free Nitrie Examination Gloves, OrangeShen Wei (Usa), Inc. · 2012
- Descendant · cites it directly · 1 of its ownK200150 Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested…Medline Industries, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK220825 Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC · 2022 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090194 | Powder- Free Nitrile Examination Gloves, Black Color | Shen Wei (Usa), Inc. | 2009 | — |
| 0 (this device) | K120890 | Powder-Free Nitrie Examination Gloves, Orange | Shen Wei (Usa), Inc. | 2012 | — |
| +1 | K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use… | Medline Industries, Inc. | 2020 | — |
| +2 | K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | American Nitrile Operations, LLC | 2022 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K090194 | Powder- Free Nitrile Examination Gloves, Black ColorSummary page 1…880.6250, Product Code FMC) Product Code: Nitrile -80LZA 4.0 Predicate Device Information: The predicate device is K090 194, Powder-Free Nitrile Examination Gloves, * Black Color, 07/07/2009. Class I Powder Free Nitrile Examination gloves,… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with… | 2020 | 1 |
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?
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
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/K120890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120890: Powder-Free Nitrie Examination Gloves, Orange.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120890
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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