This article analyzes FDA (510(k)) and CE (MDR/PPE) regulatory requirements for nitrile gloves in the U.S. and EU markets, covering classification, testing standards (ASTM/EN), and compliance strategies. It provides guidance for manufacturers navigating global certifications.

For hands, it is important to choose gloves that provide effective protection against chemicals.The EN 374: 2016 standard serves as a crucial reference for the selection and use of protective gloves against chemicals. As new substances and risks emerge, the standard is constantly being updated to adapt to new changes. Let's take a look at the latest changes in EN 374:2016!