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.

Looking for the perfect gloves to protect you from the hazards of the workplace? Look no further than the EN 388:2016 standard! With this amazing standard, workers can easily determine which gloves offer the ideal level of protection against mechanical risks.

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.

Kingfa Medical has broken through technical barriers in NC membrane production, achieving domestic substitution with its self-developed nitrocellulose membrane. Featuring international advanced standards in uniformity and long-term stability, the membrane offers high protein binding capacity, a uniform microporous structure, and strict quality control ensuring batch-to-batch consistency. This innovation provides reliable solutions for immunodiagnostic reagents, bolstering domestic IVD competitiveness in the global market.

In high-risk dental environments, effective infection control starts with precision protection. CDC guidelines mandate nitrile gloves for their superior barrier against pathogens and chemicals. This article explores how advanced nitrile gloves enhance tactile sensitivity in procedures from implants to pediatric care, while ensuring compliance with OSHA standards.