510(k) · Cleared
ClearedMedline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl)
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 Oct 26, 2020 as substantially equivalent to K120890 (Shen Wei (Usa), Inc., 2012) after a 278-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it.
- Decided
- Oct 26, 2020
- Review
- 278 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090194 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK090194 Powder- Free Nitrile Examination Gloves, Black ColorShen Wei (Usa), Inc. · 2009
- 1 generation backK120890 Powder-Free Nitrie Examination Gloves, OrangeShen Wei (Usa), Inc. · 2012
- This deviceK200150 Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested…Medline Industries, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK220825 Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K220825Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use… | Medline Industries, Inc. | 2020 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K120890 | Powder-Free Nitrie Examination Gloves, OrangeSummary page 4…e: LZA, QDO Classification Panel: General Hospital Regulation #: 21 CFR 880.6250 Predicate Device Shen Wei (USA), Inc.: Powder-Free Nitrile Examination Gloves (Orange), K120890 Device Description The Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) are non-ster… | 2012 |
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 |
|---|---|---|---|
| K220825 | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves | 2022 | 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 11 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K220825 (American Nitrile Operations, LLC, 2022) 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. 2020, 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 a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
It has also been tested for use against Fentanyl Citrate, ASTM D6978-05 (Reapproved 2019, Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
Drugs Tested: Breakthrough Time (Minutes)
Fentanyl Citrate, 100mcg/2mL >240 min
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200150: Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200150
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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