510(k) · Cleared
ClearedCardinal Health Nitrile Blue 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
Cardinalhealth · LZA Polymer Patient Examination Glove
Cleared on Sep 2, 2026 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 2, 2026
- 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. 2026, 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 purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. This glove has been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, “Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.” Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in…
Read the full statement (164 words)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. This glove has been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, “Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.”
Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time in Minutes 0.01μg/cm2 (ASTM D 6978): Carmustine (3.3 mg/mL) 20, Cisplatin (1.0 mg/mL) >240, Cyclophosphamide (20 mg/mL) >240, Dacarbazine (DTIC) 10 mg/mL >240, Doxorubicin Hydrochloride (2.0 mg/mL) >240, Etoposide (20 mg/mL) >240, 5-Fluorouracil (50 mg/mL) >240, Ifosfamide (IFEX) (50 mg/mL) >240, Mitoxantrone (2.0 mg/mL) >240, Paclitaxel (6.0 mg/mL) >240, Thiotepa (10 mg/mL) 30, Vincristine Sulfate (Oncovin) (1 mg/mL) >240.
Resists permeation of Fentanyl Citrate injection 100mcg/2mL for up to 240 minutes.
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3mg/mL): 20 minutes; Thiotepa (10.0mg/mL): 30 minutes.
Warning: Do not use with Carmustine (3.3mg/mL) and Thiotepa (10.0mg/mL).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K261749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261749: Cardinal Health Nitrile Blue 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/K261749
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026