510(k) · Cleared
ClearedShowa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Showa Best Glove, Inc. · LZC Medical Glove, Specialty
Cleared on May 6, 2019 as substantially equivalent to K082125 (Best Glove, Inc., 2008) after a 96-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- May 6, 2019
- Review
- 96 days
- Class
- Class I
- Product code
- LZC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K902696 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK902696 N-DEXMoss Point Glove Co. · 1990
- 3 generations backK992170 N-Dex Blue Powder-Free Nitrile Medical Examination GloveBest Manufacturing Company · 1999
- 2 generations backK012899 Green Nitrile Powder-Free Medical Exmaination GloveBest Manufacturing Company · 2001
- 1 generation backK082125 N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder…Best Glove, Inc. · 2008
- This deviceK190159 Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile…Showa Best Glove, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK252075 Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K252075Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902696 | N-DEX | Moss Point Glove Co. | 1990 | — |
| −3 | K992170 | N-Dex Blue Powder-Free Nitrile Medical Examination Glove | Best Manufacturing Company | 1999 | — |
| −2 | K012899 | Green Nitrile Powder-Free Medical Exmaination Glove | Best Manufacturing Company | 2001 | — |
| −1 | K082125 | N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free… | Best Glove, Inc. | 2008 | — |
| 0 (this device) | K190159 | Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | Showa Best Glove, Inc. | 2019 | — |
| +1 | K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 |
|---|---|---|---|
| * | K082125 | N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFTSummary page 4…Device: a. Name: N-DEX NightHawk® Black Nitrile Powder-Free Medical Examination Glove (Black), Non-Sterile b. Submission Number: K082125 IV. Description of Device: The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable dev… | 2008 |
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 |
|---|---|---|---|
| K252075 | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | 2025 | 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 29 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K252075 (Program Insite, LLC, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner’s hand or fingers to prevent contamination between patient and examiner.
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/K190159 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190159: Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190159
Report an extraction error
Are you the manufacturer?
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