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.
In the medical field, surgical gowns, isolation gowns and protective gowns are the three most common types of personal protective equipment (PPE). In this article, we will explore the differences between these three types of protective equipment in a variety of ways in order to achieve precise application in specific scenarios.