510(k) · Cleared
ClearedCardinal Health Nitrile Examination Gloves Extended Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinalhealth · LZC Medical Glove, Specialty
Cleared on Jan 14, 2026 after a 173-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 14, 2026
- Review
- 173 days
- Class
- Class I
- Product code
- LZC
- 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 LZC? 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 LZC device
- #1 K201390 Medline Powder-Free Light Blue Nitrile Exam…score 19.2 · 5 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 LZC devicesLZC Medical Glove, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LZC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZC
85in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZC
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZC
10in 2025
MAUDE reports naming product code LZC, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 166 | 1 | 0 |
| 2009 | 5 | 253 | 0 | 1 |
| 2010 | 5 | 68 | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 4 | 149 | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 258 | 0 | 5 |
| 2017 | 6 | 121 | 0 | 7 |
| 2018 | 6 | 105 | 0 | 6 |
| 2019 | 7 | 200 | 0 | 8 |
| 2020 | 3 | 167 | 0 | 1 |
| 2021 | 3 | 94 | 1 | 2 |
| 2022 | 7 | 85 | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 1 | — |
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. The gloves was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978, “Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs”. The following drugs have been tested with these gloves: Chemotherapy Drug &…
Read the full statement (349 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. The gloves was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978, “Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs”.
The following drugs have been tested with these gloves:
Chemotherapy Drug & Concentration Minimum Breakthrough Detection Time in Minutes, 0.01 pg/cm2/min:
Bendamustine HCI, 5 mg/ml (5,000 ppm) >240 min
Bleomycin Sulfate, 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
Carmustine 3.3 mg/ml (3,300 ppm) 10.0 min
Chloroquine, 50 mg/ml (50,000 ppm) >240 min
Cisplatin, 1mg/ml (1000 ppm) >240 min
Cyclophosphamide 20mg/ml (20,000 ppm) >240 min
Cytarabine HCI (Cytosine), 100 mg/ml (100,000 ppm) >240 min
Dacarbazine (DTIC), 10 mg/ml (10,000 ppm) >240 min
Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 min
Epirubicin HCI, 2 mg/ml (2,000 ppm) >240 min
Etoposide, 20 mg/ml (20,000 ppm) >240 min
Fludarabine, 25 mg/ml (25,000 ppm) >240 min
Fluorouracil (5 Flu), 50mg/ml (50,000ppm) >240 min
Gemcitabine HCI, 38 mg/ml (38,000 ppm) >240 min
Idarubicin HCI, 1 mg/ml (1,000 ppm) >240 min
[fosfamide (IFEX), 50 mg/ml (50,000 ppm) 80.0 min
Mechlorethamine HCI, 1 mg/ml (1,000 ppm) >240 min
Melphalan HCI, 5 mg/ml (5,000 ppm) >240 min
Methotrexate, 25mg/ml (25,000ppm) >240 min
Mitomycin C, 0.5mg/ml (500 ppm) >240 min
Mitoxantrone HCI (2.0 mg/mL) (2000 ppm) >240 min
Oxaliplatin, 5 mg/ml (5,000 ppm) >240 min
Paclitaxel, 6mg/ml (6,000ppm) >240 min
Rituximab, 10 mg/ml (10,000 ppm) >240 min
Thiotepa, I0mg/ml (10,000ppm) 20.0 min
Trisenox (Arsenic Trioxide), 1 mg/ml (1,000 ppm) >240 min
Vincristine sulfate, 1mg/ml (1000 ppm) >240 min
Vinorelbine, 10 mg/ml (10,00 ppm) >240 min
Opioid Drug Minimum Breakthrough Detection Time in Minutes, 0.01 µg/cm2/min:
Fentanyl Citrate Injection, 100mcg/2mg >240 min
*Please note that the following drugs have low permeation times:
Carmustine: 10.0 minutes, Thiotepa: 20.0 minutes
Warning: Do not use with Carmustine & Thiotepa.
Caution: Testing showed breakthrough time of 80.0 minutes with lfosfamide IFEX (50.0 mg/ml).
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/K252313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252313: Cardinal Health Nitrile Examination Gloves Extended Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252313
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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