Fssc, LLC

Fssc, LLC specializes in single-use, non-antimicrobial surgical and medical face masks. These devices are designed for clinical and procedural use in healthcare settings, such as the Indiana Face Mask and the IFM Surgical Mask Model SM3. The focus is on disposable protective barriers for patients and healthcare providers.

Fssc, LLC is based in the United States. Since the company operates within the US market, its devices are subject to FDA regulations, including classification as Class II devices. This classification requires compliance with specific FDA pathways, such as the 510(k) premarket notification process and Unique Device Identifier (UDI) requirements, ensuring traceability and safety standards are met.

Fssc, LLC’s devices are listed under FDA-recognized pathways, specifically the 510(k) premarket submission process and the Unique Device Identifier (UDI) system. These registries ensure that the company’s products meet FDA requirements for Class II devices, including compliance with labeling, performance, and manufacturing standards.

Fssc, LLC’s face masks are classified as Class II devices under US regulations. This classification is determined by the FDA based on the level of risk associated with the product. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance, which aligns with the protective nature of disposable surgical masks.