510(k) · Cleared
ClearedNitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hartalega NGC Sdn. Bhd. · LZA Polymer Patient Examination Glove
Cleared on Aug 24, 2015 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 24, 2015
- Review
- 97 days
- Class
- Class I
- Product code
- LZA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
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 | — |
What is it indicated for?
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue) is non — sterile disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are; Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes) Carmustine 33 0.1…
Read the full statement (366 words)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue) is non — sterile disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes)
Carmustine 33 0.1
Cisplatin 1.0 >240
Cyclophosphamide (Cytoxan) 20.0 >240
Dacarbazine 10.0 >240
Doxorubixin Hydrochloride 2.0 >240
Etoposide 20.0 >240
Fluoroucil 50.0 >240
Methotrexate 25.0 >240
Mitomycin 0.5 >240
Paclitaxel 6.0 >240
Thiotepa 10.0 20.4
Vincristine Sulfate 1.0 >240
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 0.1 and 20.4 minutes respectively.
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Orange) is non — sterile disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes)
Carmustine 33 20.3
Cisplatin 1.0 >240
Cyclophosphamide (Cytoxan) 20.0 >240
Dacarbazine 10.0 >240
Doxorubixin Hydrochloride 2.0 >240
Etoposide 20.0 >240
Fluoroucil 50.0 >240
Methotrexate 25.0 >240
Mitomycin 0.5 >240
Paclitaxel 6.0 >240
Thiotepa 10.0 50.6
Vincristine Sulfate 1.0 >240
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 20.3 and 50.6 minutes respectively.
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is non — sterile disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
Chemotherapy Drugs Concentration (mg/ml) Breakthrough time (minutes)
Carmustine 33 20.4
Cisplatin 1.0 >240
Cyclophosphamide (Cytoxan) 20.0 >240
Dacarbazine 10.0 >240
Doxorubixin Hydrochloride 2.0 >240
Etoposide 20.0 >240
Fluoroucil 50.0 >240
Methotrexate 25.0 >240
Mitomycin 0.5 >240
Paclitaxel 6.0 >240
Thiotepa 10.0 71.0
Vincristine Sulfate 1.0 >240
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 20.4 and 71.0 minutes respectively.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151343: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (white, blue, orange).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151343
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026