510(k) · Cleared
ClearedPowder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Central Medicare Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Jan 22, 2015 after a 71-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 13 later devices descend from it.
- Decided
- Jan 22, 2015
- Review
- 71 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK143247 Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and…Central Medicare Sdn Bhd · 2015
- Descendant · cites it directly · 12 of its ownK172642 Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd · 2017
- Descendant · 2 generations on · 10 of its ownK190942 Disposable Powder Free Nitrile Examination Glove, Pink/Black ColorEver Growth (Vietnam) Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK210463 Thermoplastic Elastomer (TPE) Hybrid Examination GloveXuzhou Full Sun Medical Products, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK233740 Black Nitrile Powder Free Patient Examination Glove, Non SterileW.A. Rubbermate Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK222103 Nitrile Patient Examination Gloves, Powder Free, Pink ColorShandong Yinghng Medical Products Co., Ltd. · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K172642Orange Non Sterile Powder Free Nitrile Examination GlovesCentral Medicare Sdn Bhd · 2017 · cites it directly12descendants
- K190942Disposable Powder Free Nitrile Examination Glove, Pink/Black ColorEver Growth (Vietnam) Co., Ltd. · 2020 · 2 generations on10descendants
- K210463Thermoplastic Elastomer (TPE) Hybrid Examination GloveXuzhou Full Sun Medical Products, Ltd. · 2022 · 3 generations on1descendant
- K233740Black Nitrile Powder Free Patient Examination Glove, Non SterileW.A. Rubbermate Co., Ltd. · 2024 · 3 generations on0descendants
- K222103Nitrile Patient Examination Gloves, Powder Free, Pink ColorShandong Yinghng Medical Products Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White… | Central Medicare Sdn Bhd | 2015 | — |
| +1 | K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | Central Medicare Sdn Bhd | 2017 | — |
| +2 | K190942 | Disposable Powder Free Nitrile Examination Glove, Pink/Black Color | Ever Growth (Vietnam) Co., Ltd. | 2020 | — |
| +3 | K210463 | Thermoplastic Elastomer (TPE) Hybrid Examination Glove | Xuzhou Full Sun Medical Products, Ltd. | 2022 | — |
| +3 | K233740 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | W.A. Rubbermate Co., Ltd. | 2024 | — |
| +3 | K222103 | Nitrile Patient Examination Gloves, Powder Free, Pink Color | Shandong Yinghng Medical Products Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172642 | Orange Non Sterile Powder Free Nitrile Examination Gloves | 2017 | 12 |
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?
- Of its descendants, K172642 (Central Medicare Sdn Bhd, 2017) has gone furthest, with 12 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. 2015, 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 | — |
https://510kreport.com/device/K143247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143247: Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143247
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026