510(k) · Cleared
ClearedPowder- Free Nitrile Examination Gloves, Black Color
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 Jul 7, 2009 after a 161-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jul 7, 2009
- Review
- 161 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK090194 Powder- Free Nitrile Examination Gloves, Black ColorShen Wei (Usa), Inc. · 2009
- Descendant · cites it directly · 2 of its ownK120890 Powder-Free Nitrie Examination Gloves, OrangeShen Wei (Usa), Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK200150 Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested…Medline Industries, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK220825 Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK121528 Power-Free Nitrile Examination Gloves, Peppermint Scented, Blue ColorShen Wei (Usa), Inc. · 2012
Most influential descendants
Showing 4 of 4 · See all- K120890Powder-Free Nitrie Examination Gloves, OrangeShen Wei (Usa), Inc. · 2012 · cites it directly2descendants
- K200150Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with…Medline Industries, Inc. · 2020 · 2 generations on1descendant
- K220825Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC · 2022 · 3 generations on0descendants
- K121528Power-Free Nitrile Examination Gloves, Peppermint Scented, Blue ColorShen Wei (Usa), Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090194 | Powder- Free Nitrile Examination Gloves, Black Color | Shen Wei (Usa), Inc. | 2009 | — |
| +1 | K120890 | Powder-Free Nitrie Examination Gloves, Orange | Shen Wei (Usa), Inc. | 2012 | — |
| +2 | K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use… | Medline Industries, Inc. | 2020 | — |
| +3 | K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | American Nitrile Operations, LLC | 2022 | 4 |
| +1 | K121528 | Power-Free Nitrile Examination Gloves, Peppermint Scented, Blue Color | Shen Wei (Usa), Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (4)
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, K120890 (Shen Wei (Usa), Inc., 2012) 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. 2009, 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 for over-the counter use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K090194 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090194: Powder- Free Nitrile Examination Gloves, Black Color.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090194
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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