OPJ — Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs Class I
FDA product code OPJ covers "Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs", a Class I medical device regulated under 21 CFR 880.6250. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- OPJ
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.