The ASTM F2100-21 standard defines the performance requirements for medical face masks in the US, ensuring their quality and safety. It covers key tests such as fluid resistance, bacterial filtration efficiency (BFE), and particle filtration efficiency (PFE).
The EU market features various face masks, including surgical masks, FFP2/FFP3 respirators, and cloth masks, each offering different protection levels. This guide covers the types, standards, and applications of face masks available in Europe.
Melt-blown fabric, made of polypropylene, is the core material of face masks. With fiber diameters of 1-5 microns, its unique structure enhances filtration, shielding, thermal insulation, and oil absorption.
Kingfa Medical, established in 2020, entered the face mask production industry with a focus on innovative materials and high-quality standards. Our masks exceed global certification requirements, with advanced filtration efficiency, low resistance, and enhanced breathability. With proprietary technologies ensuring superior protection, comfort, and reliability, Kingfa Medical definitely becomes a trusted choice for governments and leading enterprises worldwide.
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.