510(k) · Cleared
ClearedNitrile Powder-Free Medical Examination Glove (Brown)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Best Manufacturing Company · LZA Polymer Patient Examination Glove
Cleared on Aug 1, 2001 as substantially equivalent to K992170 (Best Manufacturing Company, 1999) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 1, 2001
- Review
- 21 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902696 (1990). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK902696 N-DEXMoss Point Glove Co. · 1990
- 1 generation backK992170 N-Dex Blue Powder-Free Nitrile Medical Examination GloveBest Manufacturing Company · 1999
- This deviceK012166 Nitrile Powder-Free Medical Examination Glove (Brown)Best Manufacturing Company · 2001
- Descendant · cites it directly · 0 of its ownK030075 Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and…Best Manufacturing Company-Distribution Center · 2003
- Descendant · cites it directly · 0 of its ownK022024 Nitrile Powder-Free Medical Examination Glove (Green)Best Manufacturing Company · 2002
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 |
|---|---|---|---|---|---|
| −2 | K902696 | N-DEX | Moss Point Glove Co. | 1990 | — |
| −1 | K992170 | N-Dex Blue Powder-Free Nitrile Medical Examination Glove | Best Manufacturing Company | 1999 | — |
| 0 (this device) | K012166 | Nitrile Powder-Free Medical Examination Glove (Brown) | Best Manufacturing Company | 2001 | — |
| +1 | K030075 | Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and Non-Textured) | Best Manufacturing Company-Distribution Center | 2003 | — |
| +1 | K022024 | Nitrile Powder-Free Medical Examination Glove (Green) | Best Manufacturing Company | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K992170 | N-Dex Blue Powder-Free Nitrile Medical Examination GloveSummary page 1…ree Medical Examination Glove Non-Sterile Nitrile Powder-Free Patient Examination Glove Patient Examination Glove N-DEX Nitrile Powder-Free Medical Examination Glove, K992170; and HPI Brown Nitrile Surgical Glove, K915086 Nitrile rubber films form an excellent barrier to body fluids and bloodborne pat… | 1999 |
| * | K915086 | Hpi Brown Nitrile Sensi-Grip Surgical GlovesSummary page 1…ile Powder-Free Patient Examination Glove Patient Examination Glove N-DEX Nitrile Powder-Free Medical Examination Glove, K992170; and HPI Brown Nitrile Surgical Glove, K915086 Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. b. Scientific concepts that form the b… | 1992 |
What descends from it? (2)
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K030075 (Best Manufacturing Company-Distribution Center, 2003) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K992170.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Nitrile Powder-Free Medical Examination Glove (brown) 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012166: Nitrile Powder-Free Medical Examination Glove (Brown).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012166
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026