OPJ

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product code

OPJ

Device name

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Device class

Class 1

21 CFR

21 CFR 880.6250

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Third-party review eligible

FDA classification definition

A disposable medical glove (examination or surgeons) that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various concentrations and types of chemotherapy drugs using test such as astm d6978-05, standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs.

Definition text from the FDA device classification database (U.S. federal government work, public domain).