FDA product code OPJ

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

General Hospital·Class 1·21 CFR 880.6250
US regulatory classifications
US Product Code (FDA)
OPJ
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 880.6250
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.