510(k) · Cleared
ClearedPowder Free Blue Nitrile Examination Glove Tested with Chemotherapy Drugs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tekmedic (M) Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Jan 18, 2013 after a 232-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 18, 2013
- Review
- 232 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. 2013, 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 powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection time are as follows: Chemotherapy Drugs & concentration Average Breakthrough Detection Time Carmustine (BCNU), 3300ppm. 60.2 Cisplatin, IOO0ppm > 240 min Cycaophosphamide (Cytoxan), 20,000 ppm > 240…
Read the full statement (153 words)
A powder free nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs and their breakthrough detection time are as follows:
Chemotherapy Drugs & concentration Average Breakthrough Detection Time
Carmustine (BCNU), 3300ppm. 60.2
Cisplatin, IOO0ppm > 240 min
Cycaophosphamide (Cytoxan), 20,000 ppm > 240 min
Dacarbazine (DTIC), 10,000 ppm > 240 min
Doxomubicin Hydrochloride, 2000 ppm > 240 min
Etoposide (Toposar), 20,000 ppm > 240 min
Fluorouracil, 50,000 ppm > 240 min
Ifosfami~de, 50,000 ppm > 240 win
Methotrexate, 25,000 ppm > 240 min
Mitomycin C, 500 ppm > 240 min
Mitoxantrane, 2000 ppm > 240 min
Paclitaxel (Taxol), 6000 ppm > 240 win
Thiothepa, 10,000 ppm 105.6
Vincristine Sulfate, 1000 ppm >240 min
Please note that the following drugs have low permeation times:
Carnrnstine - 60.2 minutes
Thiothepa - 105.6 minutes
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K121592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121592: Powder Free Blue Nitrile Examination Glove Tested 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/K121592
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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