510(k) · Cleared
ClearedRS Orange 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 Jun 23, 2014 as substantially equivalent to K100603 (Riverstone Resources Sdn Bhd, 2010) and 1 other predicate after a 249-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Jun 23, 2014
- Review
- 249 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K100603 (2010). No later device cites it as a predicate yet.
- 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 deviceK133193 RS Orange Nitrile Medical Examination Gloves (Powder Free)Riverstone Resources Sdn Bhd · 2014
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) | K133193 | RS Orange Nitrile Medical Examination Gloves (Powder Free) | Riverstone Resources Sdn Bhd | 2014 | — |
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 1…Marketed Device: Class I patient Examination gloves,Powder Free,LZA which meets all the requirement of ASTM D 6319-10 and FDA 21 CER 880.6250.1t is-equivalent to K 100603, RS Safe Blue Nitrile Medical Examination Gloves Powder Free ( Non- Sterile ) and KI 12928, RS White Nitrice Examination glov… | 2010 |
| * | K112928 | RS Safe White Nitrile Medical Examination Gloves Powder Free or Other Proprietary NameSummary page 3…Gloves Powder Free Gloves Powder Free (Powder Free) (NnStele ) K 100603 (Non-Sterile ) K 112928 K133193 Product Code LZA LZA… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 1 company; a new generation was cleared every 2.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 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 hand or finger to prevent contamination between patient and examiner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133193: RS Orange 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/K133193
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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