The 510(k) certification endows The Mask Lab, the marketing authorisation needed to supply the US healthcare and business community, including the public, with the 3 Ply surgical masks
Control Print is the fourth Indian mask manufacturer since the COVID-19 outbreak in 2020 to receive the USFDA 510(k) authorisation. The 510(k) certification endows The Mask Lab, a venture by Control Print, the marketing authorisation needed to supply the US healthcare and business community, including the public, with the 3 Ply surgical masks to protect from the transfer of microorganisms, body fluids, and particulate material.
Basant Kabra, Managing Director at Control Print said, “In addition to medical and frontline workers, our competitively priced 3 Ply surgical masks (ASTM Level 3) with melt-blown filtration media, N95 respirators (under review by NIOSH), and FFP2 masks (willow/cone designs with an option for valves) are designed for comfort and protection of factory workers and office employees by preventing the spread of germs by talking, coughing, or sneezing. High-quality masks are a vital compliance tool for industries mandating a heightened level of hygiene and safety in healthcare, pharmaceutical, hospitality, and food service businesses, including those exposed to high dust levels and other pollutants in manufacturing, transport, textiles, cement, and construction industries.”
Shiva Kabra, Joint Managing Director at Control Print added, “When the COVID-19 outbreak began, we swiftly ramped up our manufacturing capabilities to help Indian frontline workers with the domestic face mask shortage, including corporations with large workforces like Unilever, Tata Group, ITC Limited, United Breweries and hotels of the Taj group. We are ready to play a key role in restraining the current pandemic and equipping the world to be more prepared for the next similar challenge.”