510(k) · Cleared
ClearedChlorinated Powder Free Nitrile Examination Gloves (Black Colour)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Worldmed Manufacturing Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Feb 11, 2013 as substantially equivalent to K112924 (Riverstone Resources Sdn Bhd, 2012) and 1 other predicate after a 131-day review. Its family tree reaches back 2 generations to 2010. 2 later devices descend from it.
- Decided
- Feb 11, 2013
- Review
- 131 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K100603 (2010). 3 ancestors in all, the oldest K061553 (2006). 2 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 deviceK123116 Chlorinated Powder Free Nitrile Examination Gloves (Black Colour)Worldmed Manufacturing Sdn. Bhd. · 2013
- Descendant · cites it directly · 0 of its ownK161099 Powder Free Nitrile Examination Gloves, BlackPt. Maja Agung Latexindo · 2017
- Descendant · cites it directly · 0 of its ownK151528 Powder Free Nitrile (Black) Examination GlovesGallant Quality Sdn. Bhd. · 2015
Most influential descendants
Showing 2 of 2 · See allView 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) | K123116 | Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) | Worldmed Manufacturing Sdn. Bhd. | 2013 | — |
| +1 | K161099 | Powder Free Nitrile Examination Gloves, Black | Pt. Maja Agung Latexindo | 2017 | — |
| +1 | K151528 | Powder Free Nitrile (Black) Examination Gloves | Gallant Quality Sdn. Bhd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K112924 | RS Safe Black Nitrile Medical Examination Gloves Powder or Other Proprietary NameSummary page 1…laimed: Primary Predicate: RS BLACK Black Nitrile Medical Examination Gloves (Powder Free) Company: Riverstone Resources Sdln. Bhd. 510(K): K112924 Additional Predicate: Non-Sterile, Powder-Free, Black Nitrile Examination Glove Company: YTY Industry (M… | 2012 |
| * | K061553 | Non-Sterile, Powder-Free Black Nitrile Examination GlovesSummary page 1…2924 Additional Predicate: Non-Sterile, Powder-Free, Black Nitrile Examination Glove Company: YTY Industry (Manjung) Sdn. Bhd. 510O(K) : K061553 4.0 Description of the Device: The Chlorinated Powder Free Nitrile Examination Gloves (Black Colour) meets all the… | 2006 |
What descends from it? (2)
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 3 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K161099 (Pt. Maja Agung Latexindo, 2017) has gone furthest, with 0 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. 2013, 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?
Chlorinated Powder Free Nitrite Examination Gloves (Black Colour) is a single use device intended for medical purposes that Is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123116: Chlorinated Powder Free Nitrile Examination Gloves (Black Colour).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123116
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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