510(k) · Cleared
ClearedNitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercator Medical (Thailand), Ltd. · LZA Polymer Patient Examination Glove
Cleared on Feb 21, 2022 after a 105-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 21, 2022
- Review
- 105 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. 2022, 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?
Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner’s hands to prevent contamination between patent and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drugs Permeation.…
Read the full statement (435 words)
Nitrylex® Classic Powder Free Nitrile Blue Examination Gloves Tested for use with Chemotherapy Drugs are disposable devices intended for medical propose that are worn on the examiner’s hands to prevent contamination between patent and examiner.
The proposed device was tested for use with Chemotherapy Drugs as per ASTM D678-05 Standard Practice for Assessment Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drugs Permeation.
The following chemicals have been tested with the proposed device.
Test Chemotherapy Drugs — Concentration — Breakthrough Detection (Time In Minutes)
Bleomycin Sulfatte — 15 mg/ml (15,000 ppm) — >240 min.
Busulfan — 6 mg/ml (6,000 ppm) — >240 min.
Carboplatin — 10 mg/ml (10,000 ppm) — >240 min.
Cisplatin — 1 mg/ml (1,000 ppm) — >240 min.
Cyclophosphamide (Cytoxan) — 20.0 mg/ml (20,000 ppm) — >240 min.
Cytarabine HCl — 100 mg/ml (100,000 ppm) — >240 min.
Cytovene — 10 mg/ml (10,000 ppm) — >240 min.
Dacarbazine — 10 mg/ml (10,000 ppm) — >240 min.
Daunorubicin HCl — 5 mg/ml (5,000 ppm) — >240 min.
Docetaxel — 10 mg/ml (10,000 ppm) — >240 min.
Doxorubicin HCl — 2.0 mg/ml (2,000 ppm) — >240 min.
Epirubicin HCl — 2 mg/ml (2,000 ppm) — >240 min.
Etoposide — 20.0 mg/ml (20,000 ppm) — >240 min.
Fludarabine — 25 mg/ml (25,000 ppm) — >240 min.
Fluorouracil — 50.0 mg/ml (50,000 ppm) — >240 min.
Gemcitabine — 38 mg/ml (38,000 ppm) — >240 min.
Idarubicin HCl — 1 mg/ml (1,000 ppm) — >240 min.
Ifosfamide — 50 mg/ml (50,000 ppm) — >240 min.
Irinotecan — 20 mg/ml (20,000 ppm) — >240 min.
Mechlorethamine HCl — 1 mg/ml (1,000 ppm) — >240 min.
Melphalan — 5 mg/ml (5,000 ppm) — >240 min.
Methotrexate — 25 mg/ml (25,000 ppm) — >240 min.
Mitomycin C — 0.5 mg/ml (500 ppm) — >240 min.
Mitoxantrone — 2 mg/ml (2,000 ppm) — >240 min.
Oxaliplatin — 2 mg/ml (2,000 ppm) — >240 min.
Paclitaxel — 6.0 mg/ml (6,000 ppm) — >240 min.
Rituximab — 10 mg/ml (10,000 ppm) — >240 min.
Trisenox — 1 mg/ml (1,000 ppm) — >240 min.
Vincristine Sulfate — 1 mg/ml (1,000 ppm) — >240 min.
Vinorelbine — 10 mg/ml (10,000 ppm) — >240 min.
Fentanyl Citrate Injection — 100 mcg/2 ml — >240 min.
Carmustine (BCNU) — 3.3 mg/ml (3,300 ppm) — 34.8 (39.4, 38.7, 34.8)
ThioTepa — 10.0 mg/ml (10,000 ppm) — 47.4 (48.2, 50.0, 47.4)
Please note that the following drugs showed break through detected in less than 240 minutes:
- Carmustine (BCNU), 3.3 mg/ml: 34.8 minutes
- Thiotepa (THT) 10.0 mg/ml: 47.4 minutes
Warning-Not for Use with Carmustine and Thiotepa
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K213548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213548: Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213548
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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