510(k) · Cleared
ClearedEmg Blue 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 Sep 3, 2014 as substantially equivalent to K100603 (Riverstone Resources Sdn Bhd, 2010) and 1 other predicate after an 82-day review. Its family tree reaches back 2 generations to 2010. 3 later devices descend from it.
- Decided
- Sep 3, 2014
- Review
- 82 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K100603 (2010). 3 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 backK112928 RS Safe White Nitrile Medical Examination Gloves Powder Free or…Riverstone Resources Sdn Bhd · 2012
- This deviceK141590 Emg Blue Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
- Descendant · cites it directly · 1 of its ownK180467 SBG Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK203622 Medical GlovesBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK161320 EMG Pink Nitrile Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K180467SBG Blue Nitrile Powder Free Medical Examination GloveShowa Best Glove, Inc. · 2018 · cites it directly1descendant
- K203622Medical GlovesBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2021 · 2 generations on0descendants
- K161320EMG Pink Nitrile Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2016 · cites it directly0descendants
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 | K112928 | RS Safe White Nitrile Medical Examination Gloves Powder Free or Other… | Riverstone Resources Sdn Bhd | 2012 | — |
| 0 (this device) | K141590 | Emg Blue Nitrile Medical Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| +1 | K180467 | SBG Blue Nitrile Powder Free Medical Examination Glove | Showa Best Glove, Inc. | 2018 | — |
| +2 | K203622 | Medical Gloves | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021 | — |
| +1 | K161320 | EMG Pink Nitrile Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K100603 | RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)Summary page 4…arketed 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 )… | 2010 |
| * | K112928 | RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary NameSummary page 6…Gloves Powder Free ( Powder Free) ( Non-Sterile ) K 112928 Product Code LZA LZA LZA… | 2012 |
What descends from it? (3)
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 2.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K180467 (Showa Best Glove, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K100603.
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 Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers 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/K141590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141590: Emg Blue 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/K141590
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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