Protectque Nitrile Gloves Gain 510(k) Clearance

Austin, Tex.-based Protectque’s medical-grade nitrile gloves have received 510(k) marketing clearance from the FDA.

Rated for use in chemotherapy, the newly cleared gloves are made through a collaboration with Paz Global, a UK-based nitrile glove manufacturer. During the COVID-19 pandemic, Protectque has been supplying personal protective equipment to the Department of Veteran Affairs and other federal agencies.

Earlier this year, the FDA issued a new rule requiring seven types of medical gloves classified as “reserved” Class I devices to gain 510(k) clearance. Class I devices are generally considered low-risk and do not require 510(k) clearance.