510(k) · Cleared

Cleared

N-Dex Blue Powder-Free Nitrile Medical Examination Glove

K992170510(k) TraditionalCleared Sep 7, 199971-day reviewClass I21 CFR 880.6250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Best Manufacturing Company · LZA Polymer Patient Examination Glove

Cleared on Sep 7, 1999 as substantially equivalent to K902696 (Moss Point Glove Co., 1990) after a 71-day review. Its family tree reaches back 1 generation to 1990. 8 later devices descend from it.

Decided: Sep 7, 1999
Review: 71 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K902696 (1990). 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK902696 N-DEXMoss Point Glove Co. · 1990
This deviceK992170 N-Dex Blue Powder-Free Nitrile Medical Examination GloveBest Manufacturing Company · 1999
Descendant · cites it directly · 4 of its ownK012899 Green Nitrile Powder-Free Medical Exmaination GloveBest Manufacturing Company · 2001
Descendant · 2 generations on · 2 of its ownK082125 N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder…Best Glove, Inc. · 2008
Descendant · cites it directly · 2 of its ownK012166 Nitrile Powder-Free Medical Examination Glove (Brown)Best Manufacturing Company · 2001
Descendant · 3 generations on · 1 of its ownK190159 Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile…Showa Best Glove, Inc. · 2019
Descendant · 4 generations on · 0 of its ownK252075 Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2000high 2 (2001) · low 0 (2004)2026

Most influential descendants

Showing 5 of 8 · See all

K012899Green Nitrile Powder-Free Medical Exmaination GloveBest Manufacturing Company · 2001 · cites it directly4descendants
K082125N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free, Model# 7700PFTBest Glove, Inc. · 2008 · 2 generations on2descendants
K012166Nitrile Powder-Free Medical Examination Glove (Brown)Best Manufacturing Company · 2001 · cites it directly2descendants
K190159Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile gloveShowa Best Glove, Inc. · 2019 · 3 generations on1descendant
K252075Program insite® Powder-Free, Disposable Nitrile Exam GlovesProgram Insite, LLC · 2025 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902696	N-DEX	Moss Point Glove Co.	1990	—
0 (this device)	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	—
+2	K082125	N-Dex Free Nighthawk Black Nitrile Medical Examination Glove, Powder -Free…	Best Glove, Inc.	2008	—
+1	K012166	Nitrile Powder-Free Medical Examination Glove (Brown)	Best Manufacturing Company	2001	—
+3	K190159	Showa (R) Medical Exam Glove (Green) powder-free, disposable nitrile glove	Showa Best Glove, Inc.	2019	—
+4	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
2000	1	0
2001	2	0
2002	1	0
2003	1	0
2008	1	0
2019	1	0
2025	1	0

FIG. 1 — Lineage of K992170, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K902696	N-DEX Summary page 1 …d C. Young 1999-06-16 N-DEX Nitrile Powder-Free Medical Examination Glove Non-Sterile Nitrile Powder-Free Patient Examination Glove Patient Examination Glove N-DEX, K902696 Nitrile rubber films form an excellent barrier to body fluids and bloodborne pathogens. b. Scientific concepts that form the b…	Moss Point Glove Co.	1990	—

Also cleared against K902696: 1 other device →

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K012899	Green Nitrile Powder-Free Medical Exmaination Glove	Best Manufacturing Company	2001	4
K012166	Nitrile Powder-Free Medical Examination Glove (Brown)	Best Manufacturing Company	2001	2
K030075	Nitrile Powder-Free Medical Examination Glove (Blue) (Textured and Non-Textured)	Best Manufacturing Company-Distribution Center	2003	0
K993805	Nitri-Care Nitrile Powder-Free Sterile Medical Examination Gloves (Blue, Cherry Flavored)	Best Manufacturing Company	2000	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?

Its one ancestor has no recall.
Of its descendants, K012899 (Best Manufacturing Company, 2001) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K902696.

How does its category compare?

All LZA devices

LZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZA

24in 2025

2007high 146 (2022) · low 18 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZA

110in 2025

2007high 212 (2019) · low 89 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZA

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZA

73in 2025

2007high 76 (2024) · low 2 (2008)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 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992170 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992170: N-Dex Blue Powder-Free Nitrile Medical Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992170

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