Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
OPJ · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6250
Classification
FDA Product Code
OPJ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.6250
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.