Device Type: Anesthesiology - Therapeutic
FDA Description:
A nebulizer mask is an accessory designed to deliver aerosolized medication directly to the respiratory system. Classified as a Class II device under 21 CFR 868.5630, it requires compliance with FDA standards for safety and effectiveness, including performance testing and biocompatibility. The FDA product code for nebulizer masks is CAF.
Disposable masks are single-use protective devices designed to cover the nose and mouth, providing a barrier to airborne particles, droplets, and pathogens. These devices are essential in healthcare, industrial, and public settings, offering protection against respiratory hazards and enhancing personal safety. They are commonly used by medical professionals, factory workers, and the general public during health crises or in polluted environments.Constructed from multiple layers of non-woven fabrics, disposable masks incorporate a central filtration layer made of melt-blown material to ensure high-efficiency particulate filtration. The outer layer provides splash resistance, while the inner layer ensures user comfort. The materials are carefully selected for their hypoallergenic properties, breathability, and compliance with regulatory safety standards. High-quality plastics and advanced fabric bonding techniques, such as ultrasonic welding, are used to ensure a lightweight, durable, and cost-effective product.
Designed for mass production, disposable masks are optimized for portability and rapid distribution. They are disposable by design, eliminating the need for cleaning or sterilization, which reduces cross-contamination risks. This makes them particularly well-suited for fast-paced environments such as hospitals, factories, or disaster relief operations. The product’s design focuses on achieving a balance between comfort and protection while ensuring compliance with international respiratory protection standards.
The masks’ performance is validated through rigorous testing for filtration efficiency, breathability, and durability under various environmental conditions. Their design continues to evolve, incorporating innovations such as antimicrobial coatings and biodegradable materials to meet emerging challenges in sustainability and user safety. By addressing the needs of diverse applications, disposable masks remain an indispensable tool in public health and workplace safety.