510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove (Aqua Green)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverstone Resources Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Apr 9, 2020 as substantially equivalent to K141579 (Eco Medi Glove Sdn. Bhd., 2014) after a 59-day review. Its family tree reaches back 3 generations to 2010. 4 later devices descend from it.
- Decided
- Apr 9, 2020
- Review
- 59 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K100603 (2010). 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK100603 RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)Riverstone Resources Sdn Bhd · 2010 · Recalled
- 2 generations backK112924 RS Safe Black Nitrile Medical Examination Gloves Powder or Other…Riverstone Resources Sdn Bhd · 2012
- 1 generation backK141579 Emg Black Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
- This deviceK200326 Powder Free Nitrile Examination Glove (Aqua Green)Riverstone Resources Sdn Bhd · 2020
- Descendant · cites it directly · 0 of its ownK213775 Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile GlovesAvecena Gloves Sdn Bhd · 2022
- Descendant · cites it directly · 0 of its ownK211808 Medcare Powder-Free Blue Nitrile Patient Examination GlovesDongguan Grinvald Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210990 Non-sterile Powder Free Nitrile Examination GlovesRubberex Alliance Sdn Bhd · 2021
- Descendant · cites it directly · 0 of its ownK212290 Examination gloves -Type C (Nitrile gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K213775Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile GlovesAvecena Gloves Sdn Bhd · 2022 · cites it directly0descendants
- K211808Medcare Powder-Free Blue Nitrile Patient Examination GlovesDongguan Grinvald Technology Co., Ltd. · 2022 · cites it directly0descendants
- K210990Non-sterile Powder Free Nitrile Examination GlovesRubberex Alliance Sdn Bhd · 2021 · cites it directly0descendants
- K212290Examination gloves -Type C (Nitrile gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K100603 | RS Safe Blue Nitrile Medical Examination Gloves (Powder Free) | Riverstone Resources Sdn Bhd | 2010 | 24 |
| −2 | K112924 | RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary… | Riverstone Resources Sdn Bhd | 2012 | — |
| −1 | K141579 | Emg Black Nitrile Medical Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| 0 (this device) | K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | Riverstone Resources Sdn Bhd | 2020 | — |
| +1 | K213775 | Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves | Avecena Gloves Sdn Bhd | 2022 | — |
| +1 | K211808 | Medcare Powder-Free Blue Nitrile Patient Examination Gloves | Dongguan Grinvald Technology Co., Ltd. | 2022 | — |
| +1 | K210990 | Non-sterile Powder Free Nitrile Examination Gloves | Rubberex Alliance Sdn Bhd | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K141579 | Emg Black Nitrile Medical Examination Glove Powder FreeSummary page 4…cation Name: Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA 3. Identification of The Legally Marketed Device: Predicate Device: K141579 Device Name: Emg Black Nitrile Medical Examination Glove Powder Free Device Classification Name: Patient Examination gloves (21 C… | 2014 |
What descends from it? (4)
4 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 10 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K213775 (Avecena Gloves Sdn Bhd, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141579.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Powder Free Nitrile Examination Glove (Aqua Green) is a disposable device intended
for Medical purpose that is worn on the examiner's hands or finger to prevent contamination 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/K200326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200326: Powder Free Nitrile Examination Glove (Aqua Green).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200326
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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