Understanding Your Mask
Reusable Sports Mask (RSM) is a high-performance NON-MEDICAL mask designed for work, recreation, and athletics. This mask utilizes a disposable air filter and is constructed from polyester fiber mesh with spandex edging to form a fitting, comfortable, and washable product.
What is the filter made of?
How often should I replace my filter?
The filters can be used for 48 hours or three days of heavy use making the total monthly cost of the RSM unit lower than disposable masks while providing superior fit, aesthetics, and function.
Should I purchase additional Filters with my RSM?
The filter should be replaced after 48 hours of use. We do recommend having ample filters on hand to ensure the efficacy of the mask.
Should I purchase additional Replacement Valves with my RSM?
To assemble the mask and replace filters, the valves must be manipulated and/or set aside for a short period of time. We recommend that you have a small supply of replacement valves just in case one is broken or lost. Gently cleaning the valves with antibacterial soap and warm water will help to maintain proper function.
How do manufacturers ensure personal protective equipment (PPE) is safe and effective?
To help ensure medical devices (as well as PPE) are safe and effective, the FDA has established Quality Systems Regulations and Good Manufacturing Practices. Manufacturers are expected to use these regulations and practices to maintain consistent product quality and to guide performance testing to make sure that their products conform to recognized consensus standards. For PPE, these standards may include fluid resistance, leak protection, filtering capacity, or resistance to tears and snags. When these regulations and practices are followed, they provide reasonable assurance that the device is safe and effective. FDA has also issued device-specific guidance for some products so that manufacturers understand the Agency’s expectations.