# K252313: Cardinal Health Nitrile Examination Gloves Extended Cuff

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Jan 14, 2026 after 173 days
- Product code: LZC (Medical Glove, Specialty)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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).

Source page: https://510kreport.com/device/K252313
Methodology: https://510kreport.com/methodology