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OPJClass I

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

General Hospital · 21 CFR 880.6250

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.

MDR events22All time
Recalls0All time
Registered firms308Currently listed
510(k) clearances0All time

Event type breakdown

Malfunction22

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