Control Print Limited became the fourth Indian mask manufacturer since the COVID-19 outbreak in 2020 to receive the USFDA 510(k) authorisation, one of the most rigorous regulatory compliances and globally accepted certification for surgical masks.
The 510(k) certification endows The Mask Lab, a venture by Control Print Limited, the marketing authorisation needed to supply the US healthcare and business community, including the public, with the world's highest quality medical-grade 3 Ply surgical masks to protect from the transfer of microorganisms, body fluids and particulate material, it said in a press statement
Basant Kabra, Managing Director at Control Print Limited said, "The FDA approval affirms our 3 Ply surgical masks as one of the world's premier quality masks in terms of safety and performance. It is a testament to our rigid regulatory process in manufacturing truly world-class medical products. With our robust infrastructure, advanced manufacturing technologies, and ability to rapidly scale production at The Mask Lab, we plan to meet the rising demand of healthcare facilities, medical equipment suppliers, and large businesses across the US, Europe, Asia, and major global markets."
Shiva Kabra, Joint Managing Director at Control Print Limited, said, "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."
The USFDA 510(k), BIS, CE, and ISO 13485 certifications establish that The Mask Lab's products are safe and effective for human use after extensive third-party testing for engineering performance, sterility, safety, and biocompatibility, attaining legal approval for commercial distribution worldwide.
"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," added Kabra.