510(k) · Cleared
ClearedN-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Glove, Inc. · LZA Polymer Patient Examination Glove
Cleared on Nov 21, 2008 as substantially equivalent to K012899 (Best Manufacturing Company, 2001) after a 115-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.
- Decided
- Nov 21, 2008
- Review
- 115 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902696 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK902696 N-DEXMoss Point Glove Co. · 1990
- 2 generations backK992170 N-Dex Blue Powder-Free Nitrile Medical Examination GloveBest Manufacturing Company · 1999
- 1 generation backK012899 Green Nitrile Powder-Free Medical Exmaination GloveBest Manufacturing Company · 2001
- This deviceK082125 N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder…Best Glove, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK190159 Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile…Showa Best Glove, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK252075 Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC · 2025
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 |
|---|---|---|---|---|---|
| −3 | K902696 | N-DEX | Moss Point Glove Co. | 1990 | — |
| −2 | K992170 | N-Dex Blue Powder-Free Nitrile Medical Examination Glove | Best Manufacturing Company | 1999 | — |
| −1 | K012899 | Green Nitrile Powder-Free Medical Exmaination Glove | Best Manufacturing Company | 2001 | — |
| 0 (this device) | K082125 | N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free… | Best Glove, Inc. | 2008 | — |
| +1 | K190159 | Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | Showa Best Glove, Inc. | 2019 | — |
| +2 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K012899 | Green Nitrile Powder-Free Medical Exmaination GloveSummary page 1…880.6250) 3. Predicate Device: Nitrile Powder-Free medical Examination Glove (green) Submission Number: K012899 4. Description Of Device The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove i… | 2001 |
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 |
|---|---|---|---|
| K190159 | Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | 2019 | 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K190159 (Showa Best Glove, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K012899.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The N-DEX® NightHawk® Black Nitrile Powder-Free Medical Examination Glove is a disposable device intended for medical purposes; that is worn on the examiner's hand, to prevent contamination between the patient and examiner (21 CFR 880.6250).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082125: N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082125
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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