510(k) · Cleared

Cleared

Nitri-Care Nitrile Powder-Free Sterile Medical Examination Gloves (Blue, Cherry Flavored)

K993805510(k) TraditionalCleared Mar 10, 2000122-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 Mar 10, 2000 as substantially equivalent to K992170 (Best Manufacturing Company, 1999) after a 122-day review. Its family tree reaches back 2 generations to 1990.

Decided: Mar 10, 2000
Review: 122 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K902696 (1990). No later device cites it as a predicate yet.

By dateBy generation

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 deviceK993805 Nitri-Care Nitrile Powder-Free Sterile Medical Examination Gloves…Best Manufacturing Company · 2000

View 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)	K993805	Nitri-Care Nitrile Powder-Free Sterile Medical Examination Gloves (Blue…	Best Manufacturing Company	2000	—

FIG. 1 — Lineage of K993805, 1990–2000Source: 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

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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
*	K992170	N-Dex Blue Powder-Free Nitrile Medical Examination Glove Summary page 1 …le Nitrile Powder-Free Patient Examination Glove Classification Name: Patient Examination Glove 3. PREDICATE DEVICE N-DEX Nitrile Powder-Free Medical Examination Glove, K992170 IDENTIFICATION NAME, NUMBER 4. DESCRIPTION OF DEVICE a. How the device functions: Nitrile rubber films form an excellent barrier…	Best Manufacturing Company	1999	—

Also cleared against K992170: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 10 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K992170.

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 NITRI-CARE Nitrile Powder-Free Sterile 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/K993805 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993805: Nitri-Care Nitrile Powder-Free Sterile Medical Examination Gloves (Blue, Cherry Flavored).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993805

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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