510(k) · Cleared

Cleared

RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary Name

K112928510(k) TraditionalCleared Apr 17, 2012197-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

Riverstone Resources Sdn Bhd · LZA Polymer Patient Examination Glove

Cleared on Apr 17, 2012 as substantially equivalent to K100603 (Riverstone Resources Sdn Bhd, 2010) after a 197-day review. Its family tree reaches back 1 generation to 2010. 6 later devices descend from it.

Decided: Apr 17, 2012
Review: 197 days
Class: Class I
Product code: LZA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K100603 (2010). 6 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK100603 RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)Riverstone Resources Sdn Bhd · 2010 · Recalled
This deviceK112928 RS Safe White Nitrile Medical Examination Gloves Powder Free or…Riverstone Resources Sdn Bhd · 2012
Descendant · cites it directly · 3 of its ownK141590 Emg Blue Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
Descendant · 2 generations on · 1 of its ownK180467 SBG Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc. · 2018
Descendant · 3 generations on · 0 of its ownK203622 Medical GlovesBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
Descendant · 2 generations on · 0 of its ownK161320 EMG Pink Nitrile Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2016
Descendant · cites it directly · 0 of its ownK141510 Emg White Nitrile Medical Examination Gloves (Powder Free)Eco Medi Glove Sdn. Bhd. · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014high 3 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 6 · See all

K141590Emg Blue Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014 · cites it directly3descendants
K180467SBG Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc. · 2018 · 2 generations on1descendant
K203622Medical GlovesBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021 · 3 generations on0descendants
K161320EMG Pink Nitrile Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2016 · 2 generations on0descendants
K141510Emg White Nitrile Medical Examination Gloves (Powder Free)Eco Medi Glove Sdn. Bhd. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K100603	RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)	Riverstone Resources Sdn Bhd	2010	24
0 (this device)	K112928	RS Safe White Nitrile Medical Examination Gloves Powder Free or Other…	Riverstone Resources Sdn Bhd	2012	—
+1	K141590	Emg Blue Nitrile Medical Examination Glove Powder Free	Eco Medi Glove Sdn. Bhd.	2014	—
+2	K180467	SBG Blue Nitrile Powder Free Medical Examination Glove	Showa Best Glove, Inc.	2018	—
+3	K203622	Medical Gloves	Beijing Biosis Healing Biolog Ical Technology Co., Ltd.	2021	—
+2	K161320	EMG Pink Nitrile Examination Glove Powder Free	Eco Medi Glove Sdn. Bhd.	2016	—
+1	K141510	Emg White Nitrile Medical Examination Gloves (Powder Free)	Eco Medi Glove Sdn. Bhd.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	3	0
2016	1	0
2018	1	0
2021	1	0

FIG. 1 — Lineage of K112928, 2010–2021Source: 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
*	K100603	RS Safe Blue Nitrile Medical Examination Gloves (Powder Free) Summary page 1 …ted Device: Class I patient Examination gloves, Powder Free, LZA which meets all the requirement of ASTM D 6319- 10 and FDA 21 CFR 880.6250. It is equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free (Non-Sterile) except for colour.…	Riverstone Resources Sdn Bhd	2010	24

Also cleared against K100603: 5 other devices →

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K141590	Emg Blue Nitrile Medical Examination Glove Powder Free	Eco Medi Glove Sdn. Bhd.	2014	3
K141510	Emg White Nitrile Medical Examination Gloves (Powder Free)	Eco Medi Glove Sdn. Bhd.	2014	0
K133193	RS Orange Nitrile Medical Examination Gloves (Powder Free)	Riverstone Resources Sdn Bhd	2014	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 a recall.
Of its descendants, K141590 (Eco Medi Glove Sdn. Bhd., 2014) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K100603.

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. 2012, 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?

A powder-free patient examination glove 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/K112928 · printed Nov 5, 2026

Cite this page

510(k) Report. “K112928: RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary Name.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K112928

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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