510(k) · Cleared
ClearedNon-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, 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
Yty Industry (Manjung) Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Aug 11, 2021 after a 344-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 11, 2021
- Review
- 344 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. 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 purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Aloe Vera Tested Chemotherapy Drug And Concentration Average Breakthrough…
Read the full statement (397 words)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
Aloe Vera
Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time (minutes)
Carboplatin, 10 mg/ml > 240 minutes
Carmustine, 3.3 mg/ml 11.0 minutes
Cisplatin (BCNU), 1.0 mg/ml > 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml > 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml > 240 minutes
Etoposide (Toposar), 20.0 mg/ml > 240 minutes
Fluorouracil, 50.0 mg/ml > 240 minutes
Ifosfamide, 50.0 mg/ml > 240 minutes
Methotrexate, 25 mg/ml > 240 minutes
Mitomycin C, 0.5 mg/ml > 240 minutes
Mitoxantrone, 2 mg/ml > 240 minutes
Paclitaxel (Taxol), 6.0 mg/ml > 240 minutes
ThioTEPA, 10.0 mg/ml 59.0 minutes
Vincristine Sulfate, 1.0 mg/ml > 240 minutes
The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 11.0 minutes ThioTEPA (10.0 mg/ml): 59.0 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:
Fentanyl
Tested Chemotherapy Drug And Concentration Average Breakthrough Detection Time (minutes)
Carboplatin, 10 mg/ml > 240 minutes
Carmustine, 3.3 mg/ml 15.0 minutes
Cisplatin (BCNU), 1.0 mg/ml > 240 minutes
Cyclophosphamide (Cytoxan), 20.0 mg/ml > 240 minutes
Dacarbazine (DTIC), 10.0 mg/ml > 240 minutes
Doxorubicin Hydrochloride, 2.0 mg/ml > 240 minutes
Etoposide (Toposar), 20.0 mg/ml > 240 minutes
Fluorouracil, 50.0 mg/ml > 240 minutes
Ifosfamide, 50.0 mg/ml > 240 minutes
Methotrexate, 25 mg/ml > 240 minutes
Mitomycin C, 0.5 mg/ml > 240 minutes
Mitoxantrone, 2 mg/ml > 240 minutes
Paclitaxel (Taxol), 6.0 mg/ml > 240 minutes
ThioTEPA, 10.0 mg/ml 30.1 minutes
Vincristine Sulfate, 1.0 mg/ml > 240 minutes
Fentanyl Citrate, 100mcg/2ml > 240 minutes
The following chemotherapy drugs and concentration have extremely low permeation time.
Carmustine (3.3 mg/ml): 15.0 minutes ThioTEPA (10.0 mg/ml): 30.1 minutes
WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA
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/K202536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202536: Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, 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/K202536
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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