510(k) · Cleared

Cleared

Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane White Color, Examination Gloves (Intacta Polyurethane G

K031384510(k) TraditionalCleared Jun 17, 200347-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

Yty Industry (Manjung) Sdn Bhd · LZA Polymer Patient Examination Glove

Cleared on Jun 17, 2003 as substantially equivalent to K011198 (Maxxim Medical, Inc., 2001) after a 47-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Jun 17, 2003
Review: 47 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011198 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011198 Senicare Advantix Powder Free Polyurethane Medical Examination…Maxxim Medical, Inc. · 2001
This deviceK031384 Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane…Yty Industry (Manjung) Sdn Bhd · 2003
Descendant · cites it directly · 0 of its ownK213168 Medical Examination GlovesShandong Huiwosheng Health Technology Co.,Ltd · 2022

Most influential descendants

Showing 1 of 1 · See all

K213168Medical Examination GlovesShandong Huiwosheng Health Technology Co.,Ltd · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011198	Senicare Advantix Powder Free Polyurethane Medical Examination Glove…	Maxxim Medical, Inc.	2001	—
0 (this device)	K031384	Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane White Color…	Yty Industry (Manjung) Sdn Bhd	2003	—
+1	K213168	Medical Examination Gloves	Shandong Huiwosheng Health Technology Co.,Ltd	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K031384, 2001–2022Source: 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
*	K011198	Senicare Advantix Powder Free Polyurethane Medical Examination Glove, Sensicare Advantix…	Maxxim Medical, Inc.	2001	—

Also cleared against K011198: 2 other devices →

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
K213168	Medical Examination Gloves	Shandong Huiwosheng Health Technology Co.,Ltd	2022	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, K213168 (Shandong Huiwosheng Health Technology Co.,Ltd, 2022) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K011198.

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?

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031384 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031384: Multiple Private Labeled, Non-Sterile, Powder-Free, Polyurethane White Color, Examination Gloves (Intacta Polyurethane G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031384

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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