510(k) · Cleared
ClearedPowder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
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 Aug 2, 2016 as substantially equivalent to K090412 (Gx Corporation Sdn Bhd, 2009) and 1 other predicate after a 393-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Aug 2, 2016
- Review
- 393 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K090412 (2009). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK090412 Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Gx Corporation Sdn Bhd · 2009
- This deviceK151824 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2016
- Descendant · cites it directly · 0 of its ownK183441 Powder-free Nitrile Patient Examination Glove, Green Colored…Semperit Investments Asia Pte, Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K183441Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low…Semperit Investments Asia Pte, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White). | Gx Corporation Sdn Bhd | 2009 | — |
| 0 (this device) | K151824 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low… | Kossan International Sdn Bhd | 2016 | — |
| +1 | K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low… | Semperit Investments Asia Pte, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Summary page 8…Dermatitis Potential, and Tested for Use with Chemotherapy Drugs – were previously cleared under 510(k) K120066 (product code LZA). Predicate Device: K090412 Powder Free Nitrile Examination Gloves (Pink, Green, Orange, White). This Product Does Not Contain Thiura… | 2009 |
| * | K102790 | Powder Free Nitrile Patient Examination Glove, Blue Colored Non-Sterile (Low Deramatitis…Summary page 8…Carbamate and/or Thiazole. Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs; Product code: LZA, LZC Predicate Device: K102790 Powder-Free Nitrile Patient Examination Gloves, Blue, Non-Sterile (Low Dermatitis Potential and Chemother… | 2010 |
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 |
|---|---|---|---|
| K183441 | Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low… | 2019 | 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?
How does its category compare?
All LZA devicesLZA Polymer Patient Examination Glove: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. A patient examination glove is a disposable device intended for medical purposes that is worn on the…
Read the full statement (104 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151824: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151824
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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