# K261749: Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Sep 2, 2026 after 97 days
- Product code: LZA (Polymer Patient Examination Glove)
- 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 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).

Source page: https://510kreport.com/device/K261749
Methodology: https://510kreport.com/methodology