510(k) · Cleared
ClearedEmg Black Nitrile Medical Examination Glove Powder Free
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eco Medi Glove Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Oct 17, 2014 as substantially equivalent to K112924 (Riverstone Resources Sdn Bhd, 2012) after a 126-day review. Its family tree reaches back 2 generations to 2010. 6 later devices descend from it.
- Decided
- Oct 17, 2014
- Review
- 126 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K100603 (2010). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK100603 RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)Riverstone Resources Sdn Bhd · 2010 · Recalled
- 1 generation backK112924 RS Safe Black Nitrile Medical Examination Gloves Powder or Other…Riverstone Resources Sdn Bhd · 2012
- This deviceK141579 Emg Black Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
- Descendant · cites it directly · 4 of its ownK200326 Powder Free Nitrile Examination Glove (Aqua Green)Riverstone Resources Sdn Bhd · 2020
- Descendant · 2 generations on · 0 of its ownK213775 Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile GlovesAvecena Gloves Sdn Bhd · 2022
- Descendant · 2 generations on · 0 of its ownK211808 Medcare Powder-Free Blue Nitrile Patient Examination GlovesDongguan Grinvald Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK210990 Non-sterile Powder Free Nitrile Examination GlovesRubberex Alliance Sdn Bhd · 2021
- Descendant · 2 generations on · 0 of its ownK212290 Examination gloves -Type C (Nitrile gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K200326Powder Free Nitrile Examination Glove (Aqua Green)Riverstone Resources Sdn Bhd · 2020 · cites it directly4descendants
- K213775Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile GlovesAvecena Gloves Sdn Bhd · 2022 · 2 generations on0descendants
- K211808Medcare Powder-Free Blue Nitrile Patient Examination GlovesDongguan Grinvald Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K210990Non-sterile Powder Free Nitrile Examination GlovesRubberex Alliance Sdn Bhd · 2021 · 2 generations on0descendants
- K212290Examination gloves -Type C (Nitrile gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K100603 | RS Safe Blue Nitrile Medical Examination Gloves (Powder Free) | Riverstone Resources Sdn Bhd | 2010 | 24 |
| −1 | K112924 | RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary… | Riverstone Resources Sdn Bhd | 2012 | — |
| 0 (this device) | K141579 | Emg Black Nitrile Medical Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| +1 | K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | Riverstone Resources Sdn Bhd | 2020 | — |
| +2 | K213775 | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | 2022 | — |
| +2 | K211808 | Medcare Powder-Free Blue Nitrile Patient Examination Gloves | Dongguan Grinvald Technology Co., Ltd. | 2022 | — |
| +2 | K210990 | Non-sterile Powder Free Nitrile Examination Gloves | Rubberex Alliance Sdn Bhd | 2021 | — |
| +2 | K212290 | Examination gloves -Type C (Nitrile gloves) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K112924 | RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary NameSummary page 5…keted 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 K112924, RS Black Nitrile Medical Examination Gloves Powder Free ( Non- Sterile ) . 5.0 Description of Device : Black Nitrile Me… | 2012 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K200326 (Riverstone Resources Sdn Bhd, 2020) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K112924.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LZA
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZA
110in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZA
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZA
73in 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 gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger 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/K141579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141579: Emg Black Nitrile Medical Examination Glove Powder Free.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141579
Report an extraction error
Are you the manufacturer?
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