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.

Medical face masks are considered as medical devices and regulated by national medical device regulations. Regulations will define the legal obligations, to ensure that medical face masks provide the minimum level of protection against intended risks. Specific requirements by classification are cited in the referenced performance standards.

Liquid filtration material refers to the material that can effectively retain the suspended particles or impurities in the liquid, and make the liquid pass through to achieve the purpose of purification, separation or clarification. Its basic principle is liquid through the pore or mesh structure of the material. In this process, the particles are retained due to the volume is larger than the pore size.

Cleanroom gloves are becoming the choice of more and more industries. However, many people still confused about cleanroom gloves. Now,let’s explore more about them!