Device Type: Anesthesiology - Therapeutic
FDA Description:
An oxygen mask is a Class I medical device used to deliver supplemental oxygen to patients experiencing respiratory distress or requiring oxygen therapy. It is made from medical-grade materials, ensuring safety and comfort, and is regulated by the FDA for compliance with performance and biocompatibility standards.
General Description:
An oxygen mask is a medical device used to deliver oxygen from a supply source directly to a patient’s respiratory system. Designed for use in hospitals, emergency settings, and home care, oxygen masks are essential for managing conditions such as hypoxia, chronic obstructive pulmonary disease (COPD), and acute respiratory distress.
Constructed from lightweight, medical-grade plastics, oxygen masks are designed to be comfortable and form-fitting. They typically cover the nose and mouth, with elastic straps to secure the mask to the patient’s face. The device connects to an oxygen supply through tubing, ensuring consistent and controlled delivery of oxygen. Some masks include adjustable flow valves or vents to regulate oxygen concentration and accommodate different therapeutic needs.
Oxygen masks are available in various designs, including simple face masks, non-rebreather masks, and venturi masks, each tailored for specific clinical requirements. Their design emphasizes patient comfort, ease of use, and compatibility with oxygen delivery systems.
Tested for biocompatibility and durability, oxygen masks meet stringent safety standards. Disposable or reusable options are available, catering to diverse patient and healthcare provider needs. By ensuring reliable oxygen delivery, these masks play a vital role in respiratory care across various medical settings.