510(k) · Cleared
ClearedN-DEX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moss Point Glove Co. · LYY Latex Patient Examination Glove
Cleared on Sep 5, 1990 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Sep 5, 1990
- Review
- 78 days
- Class
- Class I
- Product code
- LYY
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK902696 N-DEXMoss Point Glove Co. · 1990
- Descendant · cites it directly · 8 of its ownK992170 N-Dex Blue Powder-Free Nitrile Medical Examination GloveBest Manufacturing Company · 1999
- Descendant · 2 generations on · 4 of its ownK012899 Green Nitrile Powder-Free Medical Exmaination GloveBest Manufacturing Company · 2001
- Descendant · 3 generations on · 2 of its ownK082125 N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder…Best Glove, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK012166 Nitrile Powder-Free Medical Examination Glove (Brown)Best Manufacturing Company · 2001
- Descendant · 4 generations on · 1 of its ownK190159 Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile…Showa Best Glove, Inc. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K992170N-Dex Blue Powder-Free Nitrile Medical Examination GloveBest Manufacturing Company · 1999 · cites it directly8descendants
- K012899Green Nitrile Powder-Free Medical Exmaination GloveBest Manufacturing Company · 2001 · 2 generations on4descendants
- K082125N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFTBest Glove, Inc. · 2008 · 3 generations on2descendants
- K012166Nitrile Powder-Free Medical Examination Glove (Brown)Best Manufacturing Company · 2001 · 2 generations on2descendants
- K190159Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile gloveShowa Best Glove, Inc. · 2019 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902696 | N-DEX | Moss Point Glove Co. | 1990 | — |
| +1 | 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 | — |
| +3 | K082125 | N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free… | Best Glove, Inc. | 2008 | — |
| +2 | K012166 | Nitrile Powder-Free Medical Examination Glove (Brown) | Best Manufacturing Company | 2001 | — |
| +4 | K190159 | Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | Showa Best Glove, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYY? 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 LYY device
- #1 K202377 Palm Care Latex Examination Powder Free Glovesscore 12.7 · 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
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, K992170 (Best Manufacturing Company, 1999) has gone furthest, with 8 descendants of its own.
How does its category compare?
All LYY devicesLYY Latex Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYY
150in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYY
1in 2025
MAUDE reports naming product code LYY, 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 | 12 | 75 | 0 | 11 |
| 2008 | 13 | 151 | 0 | 14 |
| 2009 | 7 | 76 | 0 | 11 |
| 2010 | 13 | 106 | 0 | 10 |
| 2011 | 11 | 127 | 1 | 4 |
| 2012 | 11 | 133 | 0 | 1 |
| 2013 | 6 | 131 | 0 | 2 |
| 2014 | 3 | 156 | 0 | 6 |
| 2015 | 3 | 251 | 0 | 5 |
| 2016 | 4 | 142 | 0 | 7 |
| 2017 | 4 | 230 | 0 | 7 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 7 |
| 2020 | 1 | — | 1 | 1 |
| 2021 | 8 | 188 | 0 | 1 |
| 2022 | 14 | 150 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K902696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902696: N-DEX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902696
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026