510(k) · Cleared
ClearedPowder Free Nitrile Examination Glove Black and Dual Color White-Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Careplus (M) Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Aug 20, 2021 as substantially equivalent to K142858 (Careplus (M) Sdn Bhd, 2015) and 1 other predicate after a 410-day review. Its family tree reaches back 4 generations to 2007. 1 later device descends from it.
- Decided
- Aug 20, 2021
- Review
- 410 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K062764 (2007). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK062764 Powder-Free Nitrile Patient Examination Glove, White (Non-Colored)…Kossan Latex Industries (M)Sdn Bhd · 2007
- 3 generations backK111772 Powder Free Nitrile Patient Examination Glove, Blue Colored and…Kossan Latex Industries (M)Sdn Bhd · 2011
- 2 generations backK123469 Powder Free Nitrile Patient Examination Glove, Blue and White…Wear Safe (Malaysia) Sdn Bhd - Facility II · 2013
- 1 generation backK142862 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Careplus (M) Sdn Bhd · 2015
- This deviceK201857 Powder Free Nitrile Examination Glove Black and Dual Color White-BlueCareplus (M) Sdn Bhd · 2021
- Descendant · cites it directly · 0 of its ownK232550 Nitrile Examination Gloves, Dual Color Black-BlueShanxi Hongjin Plastic Technology Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232550Nitrile Examination Gloves, Dual Color Black-BlueShanxi Hongjin Plastic Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K062764 | Powder-Free Nitrile Patient Examination Glove, White (Non-Colored) and Blue… | Kossan Latex Industries (M)Sdn Bhd | 2007 | — |
| −3 | K111772 | Powder Free Nitrile Patient Examination Glove, Blue Colored and White… | Kossan Latex Industries (M)Sdn Bhd | 2011 | — |
| −2 | K123469 | Powder Free Nitrile Patient Examination Glove, Blue and White Colored… | Wear Safe (Malaysia) Sdn Bhd - Facility II | 2013 | — |
| −1 | K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). | Careplus (M) Sdn Bhd | 2015 | — |
| 0 (this device) | K201857 | Powder Free Nitrile Examination Glove Black and Dual Color White-Blue | Careplus (M) Sdn Bhd | 2021 | — |
| +1 | K232550 | Nitrile Examination Gloves, Dual Color Black-Blue | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K142858 | POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)Summary page 4…examination glove Class :I 4.0 Predicate Device Predicate device: Powder Free Nitrile Examination Glove White, 510(k) number K142858 and Powder Free Nitrile Examination Glove Blue, 510(k) number K142862, product code LZA. 5.0 Device Description… | 2015 |
| * | K142862 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).Summary page 4…ce Predicate device: Powder Free Nitrile Examination Glove White, 510(k) number K142858 and Powder Free Nitrile Examination Glove Blue, 510(k) number K142862, product code LZA. 5.0 Device Description Powder Free Nitrile Examination Glove, Black and dual color White-Blue… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232550 | Nitrile Examination Gloves, Dual Color Black-Blue | 2023 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K232550 (Shanxi Hongjin Plastic Technology Co., Ltd., 2023) has gone furthest, with 0 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. 2021, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201857: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201857
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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