# Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 145
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OPJ)
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