Vitacore Industries, Inc.

Vitacore Industries, Inc. specializes in single-use surgical and medical respirators for non-antimicrobial applications, as well as procedural masks. Their product line includes the Vitacore respirator and Vitaform Procedural Masks, which come in standard and shield-equipped versions like the Vitaform-FS. These devices are designed for clinical use in controlled environments where infection control is critical.

Vitacore Industries, Inc. is headquartered in the United States. Their devices are developed and marketed primarily for use within the U.S., where regulatory compliance aligns with FDA requirements. The company’s focus on single-use respiratory and procedural protection aligns with domestic healthcare needs.

Vitacore’s devices fall under Class II classification, which applies to products requiring special controls to ensure their safety and effectiveness. This classification is common for devices like respirators and procedural masks, where performance standards (e.g., filtration efficiency, breathability) must be rigorously validated. The company submits these devices through FDA’s 510(k) premarket notification process and UDI (Unique Device Identification) program to maintain compliance.

Vitacore’s devices are documented in the FDA’s 510(k) registry, which tracks premarket submissions for Class II devices, and the FDA’s UDI system, which assigns unique identifiers to ensure traceability and regulatory oversight. These listings reflect compliance with U.S. requirements for medical devices, including performance testing and manufacturing controls.

Vitacore’s respirators and procedural masks are designed as single-use to minimize cross-contamination risks in clinical settings. Single-use classification aligns with infection control best practices, where reusable devices require sterilization between uses—a process that can introduce additional variables (e.g., damage, microbial load). Single-use devices simplify workflows, reduce maintenance burdens, and ensure consistent performance per regulatory standards like those enforced by the FDA.