510(k) · Cleared

Cleared

Powder Free Blue Patient Nitrile Examination Glove

K082598510(k) TraditionalCleared Jan 7, 2009121-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

Tangshan Zhonghong Pulin Group Co., Ltd. · LZA Polymer Patient Examination Glove

Cleared on Jan 7, 2009 as substantially equivalent to K993247 (Jda Intl., Inc., 1999) after a 121-day review. Its family tree reaches back 1 generation to 1999. 26 later devices descend from it.

Decided: Jan 7, 2009
Review: 121 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K993247 (1999). 26 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK993247 Nitrile Powder Free Patient Examination GlovesJda Intl., Inc. · 1999
This deviceK082598 Powder Free Blue Patient Nitrile Examination GloveTangshan Zhonghong Pulin Group Co., Ltd. · 2009
Descendant · cites it directly · 16 of its ownK121992 Powder-Free Nitrile Patient Examination Gloves, Blue ColorXinwei (Shandong) Plastic and Rubber Products Co., · 2012
Descendant · 2 generations on · 15 of its ownK131440 Powder Free Nitrile Patient Examination Gloves, BlueHebei Hongsen Plastics Technology Co, Ltd. · 2013
Descendant · 3 generations on · 13 of its ownK150340 POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES…Hebei Hongsen Plastics Technology Co, Ltd. · 2015
Descendant · cites it directly · 4 of its ownK110248 Powder Free Nitrile Patient Examination Gloves, White ColorJiangsu Dongling Plastic & Rubber Co., Ltd. · 2011
Descendant · 2 generations on · 3 of its ownK171615 Xingyu Nitrile Powder Free Patient Examination Gloves, White colorShandong Xingyu Gloves Co., Ltd. · 2017

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2011high 11 (2021) · low 0 (2016)2026

Most influential descendants

Showing 5 of 26 · See all

K121992Powder-Free Nitrile Patient Examination Gloves, Blue ColorXinwei (Shandong) Plastic and Rubber Products Co., · 2012 · cites it directly16descendants
K131440Powder Free Nitrile Patient Examination Gloves, BlueHebei Hongsen Plastics Technology Co, Ltd. · 2013 · 2 generations on15descendants
K150340POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER…Hebei Hongsen Plastics Technology Co, Ltd. · 2015 · 3 generations on13descendants
K110248Powder Free Nitrile Patient Examination Gloves, White ColorJiangsu Dongling Plastic & Rubber Co., Ltd. · 2011 · cites it directly4descendants
K171615Xingyu Nitrile Powder Free Patient Examination Gloves, White colorShandong Xingyu Gloves Co., Ltd. · 2017 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993247	Nitrile Powder Free Patient Examination Gloves	Jda Intl., Inc.	1999	—
0 (this device)	K082598	Powder Free Blue Patient Nitrile Examination Glove	Tangshan Zhonghong Pulin Group Co., Ltd.	2009	—
+1	K121992	Powder-Free Nitrile Patient Examination Gloves, Blue Color	Xinwei (Shandong) Plastic and Rubber Products Co.,	2012	—
+2	K131440	Powder Free Nitrile Patient Examination Gloves, Blue	Hebei Hongsen Plastics Technology Co, Ltd.	2013	—
+3	K150340	POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue)…	Hebei Hongsen Plastics Technology Co, Ltd.	2015	—
+1	K110248	Powder Free Nitrile Patient Examination Gloves, White Color	Jiangsu Dongling Plastic & Rubber Co., Ltd.	2011	—
+2	K171615	Xingyu Nitrile Powder Free Patient Examination Gloves, White color	Shandong Xingyu Gloves Co., Ltd.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	2	0
2013	2	0
2014	1	0
2015	1	0
2017	2	0
2021	11	0
2022	4	0
2024	1	0

FIG. 1 — Lineage of K082598, 1999–2024Source: 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
*	K993247	Nitrile Powder Free Patient Examination Gloves Summary page 1 …es that meets all of the requirements of ASTM standard D 6319-05 Predicate device : Nitrile powder-free patient examination glove, JDA International Inc. k993247. I(a)(4)] A description of the device Device Description : Nitrile Powder Free Patient Examination Gloves that meets…	Jda Intl., Inc.	1999	—

Also cleared against K993247: 6 other devices →

What descends from it? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K121992	Powder-Free Nitrile Patient Examination Gloves, Blue Color	Xinwei (Shandong) Plastic and Rubber Products Co.,	2012	16
K110248	Powder Free Nitrile Patient Examination Gloves, White Color	Jiangsu Dongling Plastic & Rubber Co., Ltd.	2011	4
K133325	Blue Nitrile Powder Free Exam Gloves	Shandong Xinshi Medical Products Co., Ltd.	2014	0
K123869	Powder-Free Nitrile Patient Examination Gloves	Dehai (Shandong) Medical Gloves, Co., Ltd.	2013	0
K121526	Power-Free Nitrile Patient Examination Gloves	Shandong Junchi Medical Products Co., Ltd.	2012	0
K110247	Powder Free Nutrile Patient Examination Gloves, Blue Color	Jiangsu Dongling Plastic & Rubber Co., Ltd.	2011	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, K121992 (Xinwei (Shandong) Plastic and Rubber Products Co.,, 2012) has gone furthest, with 16 descendants of its own.
6 other devices also cite its predicate K993247.

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. 2009, this device’s year, is highlighted.

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?

Powder Free Blue Patient Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082598 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082598: Powder Free Blue Patient Nitrile Examination Glove.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082598

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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