510(k) · Cleared

Cleared

mCare Powder-free Blue Nitrile Examination Gloves

K172930510(k) TraditionalCleared Apr 13, 2018200-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

Mercator Medical (Thailand), Ltd. · LZA Polymer Patient Examination Glove

Cleared on Apr 13, 2018 as substantially equivalent to K022548 (Latexx Manufacturing Sdn.Bhd., 2002) after a 200-day review. Its family tree reaches back 1 generation to 2002. 46 later devices descend from it.

Decided: Apr 13, 2018
Review: 200 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K022548 (2002). 46 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK022548 Medtexx Blue Colour Powder-Free Nitrile Rubber Examination GlovesLatexx Manufacturing Sdn.Bhd. · 2002
This deviceK172930 mCare Powder-free Blue Nitrile Examination GlovesMercator Medical (Thailand), Ltd. · 2018
Descendant · cites it directly · 43 of its ownK192333 Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020
Descendant · 2 generations on · 8 of its ownK202384 Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd. · 2020
Descendant · 2 generations on · 6 of its ownK203191 LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd. · 2021
Descendant · 2 generations on · 2 of its ownK211515 Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 2021
Descendant · 2 generations on · 1 of its ownK221169 JR MEDIC Nitrile Examination Gloves Powder Free- BlackJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022

Showing 5 of 46 descendants. See all descendants

Descendants cleared per year

2020high 20 (2021) · low 0 (2024)2026

Most influential descendants

Showing 5 of 46 · See all

K192333Blue Nitrile Examination Gloves Powder FreeJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2020 · cites it directly43descendants
K202384Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co., Ltd. · 2020 · 2 generations on8descendants
K203191LYDUS Nitrile Examination Gloves, Powder FreeNathan Trading Co., Ltd. · 2021 · 2 generations on6descendants
K211515Nitrile Examination GlovesBeijing Reagent Latex Products Co., Ltd. · 2021 · 2 generations on2descendants
K221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackJr Engineering & Medical Technologies (M) Sdn. Bhd. · 2022 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022548	Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves	Latexx Manufacturing Sdn.Bhd.	2002	—
0 (this device)	K172930	mCare Powder-free Blue Nitrile Examination Gloves	Mercator Medical (Thailand), Ltd.	2018	—
+1	K192333	Blue Nitrile Examination Gloves Powder Free	Jr Engineering & Medical Technologies (M) Sdn. Bhd.	2020	—
+2	K202384	Palm Care Blue Nitrile Examination Gloves Powder Free	Hi-Care Thai Gloves Co., Ltd.	2020	—
+2	K203191	LYDUS Nitrile Examination Gloves, Powder Free	Nathan Trading Co., Ltd.	2021	—
+2	K211515	Nitrile Examination Gloves	Beijing Reagent Latex Products Co., Ltd.	2021	—
+2	K221169	JR MEDIC Nitrile Examination Gloves Powder Free- Black	Jr Engineering & Medical Technologies (M) Sdn. Bhd.	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	2	0
2021	20	0
2022	19	0
2023	5	0

FIG. 1 — Lineage of K172930, 2002–2023Source: 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
*	K022548	Medtexx Blue Colour Powder-Free Nitrile Rubber Examination Gloves Summary page 4 …Identification of The Legally Marketed Devices that equivalency is claimed: MEDTEXX Blue Color Powder Free Nitrile Rubber Examination Gloves, 510(k): K022548 Regulatory Class I Product Code : LZA 4.0 Description of The Device : mCare® Powder-free Nitrile Blu…	Latexx Manufacturing Sdn.Bhd.	2002	—

Also cleared against K022548: 1 other device →

What descends from it? (46)

See all 46

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

Number	Device	Applicant	Decided	Descendants
K192333	Blue Nitrile Examination Gloves Powder Free	Jr Engineering & Medical Technologies (M) Sdn. Bhd.	2020	43
K213678	Powder Free Blue Nitrile Examination Gloves	Lienteh Technology Sdn Bhd	2022	0
K213107	Powder Free Blue Nitrile Examination Gloves	Novid Ppe Sdn. Bhd.	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, K192333 (Jr Engineering & Medical Technologies (M) Sdn. Bhd., 2020) has gone furthest, with 43 descendants of its own.
1 other device also cites its predicate K022548.

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. 2018, 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?

mCare® Powder Free Nitrile Blue Examination Glove are disposable device intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

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/K172930 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172930: mCare Powder-free Blue Nitrile Examination Gloves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172930

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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