Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
The Medical Gloves With Chemotherapy Labeling Claims (product code OPJ) is a Class 1 General Hospital device regulated under 21 CFR 880.6250, cleared via 510(k). These disposable examination or surgical gloves have been specifically tested for permeation and breakthrough resistance against chemotherapy drugs using standards such as ASTM D6978-05, in addition to standard barrier protection against patient-examiner contamination. The device is eligible for third-party review and is not an implant or life-sustaining device.
Research product code OPJ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OPJ
- Device Class
- FDA class 1
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 148 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 148 registration numbers. Click on an entry to view related FDA registrations.