510(k) · Cleared
Recalled · Class II · 2016RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)
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 Jul 16, 2010 after a 135-day review. The FDA summary names its predicate without a number. 20 later devices descend from it. It has been recalled 24 times.
- Decided
- Jul 16, 2010
- Review
- 135 days
- Class
- Class I
- Product code
- LZA
- Recalls
- 24
- Predicates
- 0
20 later devices descend from it, 6 citing it directly.
- This deviceK100603 RS Safe Blue Nitrile Medical Examination Gloves (Powder Free)Riverstone Resources Sdn Bhd · 2010
- Descendant · cites it directly · 10 of its ownK112924 RS Safe Black Nitrile Medical Examination Gloves Powder or Other…Riverstone Resources Sdn Bhd · 2012
- Descendant · 2 generations on · 6 of its ownK141579 Emg Black Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
- Descendant · cites it directly · 6 of its ownK112928 RS Safe White Nitrile Medical Examination Gloves Powder Free or…Riverstone Resources Sdn Bhd · 2012
- Descendant · 3 generations on · 4 of its ownK200326 Powder Free Nitrile Examination Glove (Aqua Green)Riverstone Resources Sdn Bhd · 2020
- Descendant · cites it directly · 3 of its ownK141590 Emg Blue Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K112924RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary NameRiverstone Resources Sdn Bhd · 2012 · cites it directly10descendants
- K141579Emg Black Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014 · 2 generations on6descendants
- K112928RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary NameRiverstone Resources Sdn Bhd · 2012 · cites it directly6descendants
- K200326Powder Free Nitrile Examination Glove (Aqua Green)Riverstone Resources Sdn Bhd · 2020 · 3 generations on4descendants
- K141590Emg Blue Nitrile Medical Examination Glove Powder FreeEco Medi Glove Sdn. Bhd. · 2014 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100603 | RS Safe Blue Nitrile Medical Examination Gloves (Powder Free) | Riverstone Resources Sdn Bhd | 2010 | — |
| +1 | K112924 | RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary… | Riverstone Resources Sdn Bhd | 2012 | — |
| +2 | K141579 | Emg Black Nitrile Medical Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2014 | — |
| +1 | K112928 | RS Safe White Nitrile Medical Examination Gloves Powder Free or Other… | Riverstone Resources Sdn Bhd | 2012 | — |
| +3 | K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | Riverstone Resources Sdn Bhd | 2020 | — |
| +1 | K141590 | Emg Blue Nitrile Medical Examination Glove Powder Free | Eco Medi Glove Sdn. Bhd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 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 |
|---|---|---|---|
| * | — | Class I patient Examination gloves, Powder Free, LZA Named without a submission number |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112924 | RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary Name | 2012 | 10 |
| K112928 | RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary Name | 2012 | 6 |
| K141590 | Emg Blue Nitrile Medical Examination Glove Powder Free | 2014 | 3 |
| K171667 | Powder Free Nitrile Examination Glove | 2017 | 0 |
| K162113 | Powder Free Nitrile Examination Gloves (Blue) | 2016 | 0 |
| K133193 | RS Orange Nitrile Medical Examination Gloves (Powder Free) | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2016 | Class II | Z-1212-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1223-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1209-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1224-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1219-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1227-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1218-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1221-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1210-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1226-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1229-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1220-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1228-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1211-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1215-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1222-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1203-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1214-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1206-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1208-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1213-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1225-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1216-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
| Jan 22, 2016 | Class II | Z-1217-2016 | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria |
The 5 latest of 24 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K112924 (Riverstone Resources Sdn Bhd, 2012) has gone furthest, with 10 descendants of its own.
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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/K100603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100603: RS Safe Blue Nitrile Medical Examination Gloves (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/K100603
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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