510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kossan International Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Apr 5, 2019 after a 130-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 30 later devices descend from it.
- Decided
- Apr 5, 2019
- Review
- 130 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 3 citing it directly.
- This deviceK183287 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2019
- Descendant · cites it directly · 26 of its ownK192954 Power Free Nitrile Examination Gloves Tested for Use with…Comfort Rubber Gloves Industries Sdn. Bhd. · 2020
- Descendant · 2 generations on · 8 of its ownK221269 Powder Free Nitrile Examination Gloves (Blue),Tested for Use with…Better Care Plastic Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 3 of its ownK232266 Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non…Better Care Plastic Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK213408 BPG ChemoPlus Nitrile Patient Examination Gloves, Powder FreeMeditech Gloves Sdn Bhd · 2022
- Descendant · 2 generations on · 2 of its ownK230779 Powder Free Nitrile Examination Gloves (Black), Tested for Use with…Shanxi Hongjin Plastic Technology Co., Ltd. · 2023
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and FentanylComfort Rubber Gloves Industries Sdn. Bhd. · 2020 · cites it directly26descendants
- K221269Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and…Better Care Plastic Technology Co., Ltd. · 2022 · 2 generations on8descendants
- K232266Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for…Better Care Plastic Technology Co., Ltd. · 2023 · 3 generations on3descendants
- K213408BPG ChemoPlus Nitrile Patient Examination Gloves, Powder FreeMeditech Gloves Sdn Bhd · 2022 · 2 generations on3descendants
- K230779Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs…Shanxi Hongjin Plastic Technology Co., Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K183287 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile… | Kossan International Sdn Bhd | 2019 | — |
| +1 | K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs… | Comfort Rubber Gloves Industries Sdn. Bhd. | 2020 | — |
| +2 | K221269 | Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy… | Better Care Plastic Technology Co., Ltd. | 2022 | — |
| +3 | K232266 | Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile… | Better Care Plastic Technology Co., Ltd. | 2023 | — |
| +2 | K213408 | BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free | Meditech Gloves Sdn Bhd | 2022 | — |
| +2 | K230779 | Powder Free Nitrile Examination Gloves (Black), Tested for Use with… | Shanxi Hongjin Plastic Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 10 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (30)
See all 303 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192954 | Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl | 2020 | 26 |
| K200181 | Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy… | 2020 | 1 |
| K210330 | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with… | 2022 | 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?
- Of its descendants, K192954 (Comfort Rubber Gloves Industries Sdn. Bhd., 2020) has gone furthest, with 26 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. 2019, 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/K183287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183287: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183287
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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