510(k) · Cleared
ClearedPowder-free Nitrile Patient Examination Glove, Green 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
Semperit Investments Asia Pte, Ltd. · LZA Polymer Patient Examination Glove
Cleared on Oct 4, 2019 as substantially equivalent to K151824 (Kossan International Sdn Bhd, 2016) after a 296-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Oct 4, 2019
- Review
- 296 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090412 (2009). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK090412 Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).Gx Corporation Sdn Bhd · 2009
- 1 generation backK151824 Powder Free Nitrile Patient Examination Glove, Blue Colored…Kossan International Sdn Bhd · 2016
- This deviceK183441 Powder-free Nitrile Patient Examination Glove, Green Colored…Semperit Investments Asia Pte, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K090412 | Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White). | Gx Corporation Sdn Bhd | 2009 | — |
| −1 | K151824 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low… | Kossan International Sdn Bhd | 2016 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K151824 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis…Summary page 4…ital Class I 4‐ Predicate device: 510k number Trade or Proprietary or Model Name Manufacturer K151824 ‐‐Powder Free Nitrile Patient Examination Glove, Blue KOSSAN INTERNATIONAL Colored, Non‐Ster… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 3 ancestors has a recall.
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 | — |
What is it indicated for?
This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below Minimum Breakthrough detection time (minutes) Carmustine…
Read the full statement (154 words)
This device is an ambidextrous patient examination glove that is non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs listed below
Minimum Breakthrough detection time (minutes)
Carmustine (BCNU) (3.3 mg/ml) 15.9
Cisplatin (1.0 mg/ml) >240
Cyclophosphamide (Cytoxan) (20.0 mg/ml) >240
Cytarabine (100mg/ml) >240
Dacarbazine (DTIC) (10.0 mg/ml) >240
Doxorubicin Hydrochloride (2.0 mg/ml) >240
Etoposide (20.0 mg/ml) >240
Fluorouracil (50.0 mg/ml) >240
Ifosfamide (50.0 mg/ml) >240
Methotrexate (25.0 mg/ml) >240
Mitomycin C (0.5 mg/ml) >240
Mitoxantrone (2.0 mg/ml) >240
Paclitaxel (Taxol) (6.0 mg/ml) >240
Thiotepa (10.0 mg/ml) 11.1
Vincristine Sulfate (1.0 mg/ml) >240
Do not use with Carmustine and Thiotepa.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 15.9 minutes and Thiotepa:11.1 minutes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183441 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183441: Powder-free Nitrile Patient Examination Glove, Green 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 3, 2026. https://510kreport.com/device/K183441
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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