Founded by James Bernstein, MD, and Huma Malik, Eniware, LLC develops the Eniware Portable Sterilizer, a roughly 35-pound medical-instrument sterilizer that uses nitrogen dioxide at room temperature without external electricity or water. The Delaware company grew from Bernstein’s earlier work developing NO₂ sterilization technology and is focused on bringing safe surgical sterilization to field hospitals, medical missions, disaster zones, and other resource-limited settings. Eniware maintains an ISO 13485:2016-certified quality management system.
ISO 13485:2016 Certified Quality Management System
FDA 510(k)
Compliance program
CE Mark
Propper Manufacturing Company, IncFamily-owned since its founding in 1945, Propper Manufacturing Company is a Long Island City medical-device maker known for helping healthcare professionals verify that sterilization processes have worked. Its U.S.-made products and biological monitoring service support clinical and non-clinical customers, while its OEM work adapts medical devices to the requirements of partner brands. Propper is ISO 13485:2016 certified and recently received FDA clearance for its EO Chex indicator tape.LONG ISLAND CITY, NY
NovaSterilis, IncLaunched in 2001, Lansing-based NovaSterilis develops supercritical CO2 terminal-sterilization processes, equipment, and testing services for sensitive medical products and materials. Its patented Nova Process was commercialized in 2007, and tissue sterilized through the process has been used in more than 500,000 surgeries worldwide. The company combines engineering and life-science expertise to help customers assess compatibility, develop processes, and move scCO2 solutions toward production and regulatory clearance.LANSING, NY
Red Bag SolutionsFounded by Dr. Sanford A. “Sandy” Glazer, a former U.S. Navy Dental Corps captain, Red Bag Solutions has spent more than a quarter century developing on-site medical-waste processing technology. The company serves healthcare and life-science facilities with its patented Steam Sterilization and Maceration systems, which render biohazardous waste sterile and unrecognizable at the point of generation.TOWSON, MD
BGS US LLCDrawing on radiation-sterilization expertise dating to its German founding in 1981, BGS US provides fast, residue-free electron-beam sterilization for medical products and other sensitive materials. Its Pittsburgh-area operation combines a fully automated handling system with a 100,000-plus-square-foot facility, helping customers move validated products back into time-sensitive supply chains quickly. BGS US is privately owned and operates under certifications to ISO 9001, ISO 13485, and ISO 11137.IMPERIAL, PA