510(k) · Cleared

Cleared

Ultimate N-Dex Power Free Nitrile Exmination Glove (Tested for Use with Chemotherapy Drugs)

K001375510(k) TraditionalCleared Jul 25, 200085-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 Jul 25, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Jul 25, 2000
Review: 85 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK001375 Ultimate N-Dex Power Free Nitrile Exmination Glove (Tested for Use…Best Manufacturing Company · 2000
Descendant · cites it directly · 0 of its ownK082428 N-Dex BWC Pink Nitrile Medical Examination Glove, Non SterileBest Glove, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all

K082428N-Dex BWC Pink Nitrile Medical Examination Glove, Non SterileBest Glove, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001375	Ultimate N-Dex Power Free Nitrile Exmination Glove (Tested for Use with…	Best Manufacturing Company	2000	—
+1	K082428	N-Dex BWC Pink Nitrile Medical Examination Glove, Non Sterile	Best Glove, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K001375, 2000–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082428	N-Dex BWC Pink Nitrile Medical Examination Glove, Non Sterile	Best Glove, Inc.	2009	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?

Of its descendants, K082428 (Best Glove, Inc., 2009) has gone furthest, with 0 descendants of its own.

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	—

https://510kreport.com/device/K001375 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001375: Ultimate N-Dex Power Free Nitrile Exmination Glove (Tested for Use with Chemotherapy Drugs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001375

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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