FDA product code OPJ: Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

OPJ is the FDA product code for medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. Devices under OPJ reach the market by 510(k); FDA lists no cleared 510(k)s for it.

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.

Classification

Recalls for OPJ devices

openFDA lists no recalls for product code OPJ.

Frequently asked questions

What is FDA product code OPJ?

OPJ is the FDA product code for medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.

What device class is OPJ?

Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code OPJ
• Run a recall and safety report across every OPJ manufacturer
• Watch product code OPJ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times