510(k) · Cleared
ClearedBlue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Central Medicare Sdn Bhd · LZA Polymer Patient Examination Glove
Cleared on Apr 11, 2022 after a 171-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 11, 2022
- Review
- 171 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?
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examinet's hand to prevent contamination between patient and examiner. Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of…
Read the full statement (291 words)
Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examinet's hand to prevent contamination between patient and examiner.
Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.
The following drugs and concentrations have been tested and reached the minimum breakthrough result of >240 minutes: Arsenic Trioxide 1.0; Azacitidine (Vidaza) 25.0; Bendamustine HCI 5.0; Bleomycin Sulfate 15.0; Busulfan 6.0; Carboplatin 10.0; Carfilzomib 2.0; Cetuximab 2.0; Chloroquine 50.0; Cisplatin 1.0; Cladribine 1.0; Cyclophosphamide (Cytoxan) 20.0; Cyclosporin A 100.0; Cytarabine 100.0; Cytovene (Ganciclovir) 10.0; Dacarbazine 10.0; Daunorubicin 5.0; Decitibine 5.0; Docetaxel 10.0; Doxorubicin Hydrochloride 2.0; Epirubicin (Ellence) 2.0; Etoposide (Toposar) 20.0; Fludarabine 25.0; Fluorouracil 50.0; Fulvestrant 50.0; Gemcitabine (Gemzar) 38.0; Idarubicin 1.0; Ifosfamide 50.0; Irinotecan 20.0; Mechlorethamine HCI 1.0; Melphalan 5.0; Mesna 50.0; Methotrexate 25.0; Mitomycin C 0.5; Mitoxantrone 2.0; Oxaliplatin 2.0; Paclitaxel 6.0; Paraplatin 10.0; Pemetrexed 25.0; Pertuzumab 30.0; Propofol 10.0; Raltitrexed 0.5; Retrovir 10.0; Rituximab 10.0; Temsirolimus 25.0; Topotecan HCI [.0; Trastuzumab 21.0; Triclosan 2.0; Trisenox (Arsenic Trioxide) [.0; Velcade (Bortezomib) 1.0; Vinblastine 1.0; Vincristine Sulfate [.0; Vinorelbine 10.0; Zoledronic Acid 0.8.
The following drugs have permeation times lower than 240 minutes: Carmustine: 55.1 minutes and Thiotepa: 199.2 minutes.
Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100meg/2mL) was found to have no breakthrough detected up to 240 minutes.
Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.
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/K213437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213437: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213437
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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