Control Print Limited Receives USFDA 510(K) Clearance for Commercial Distribution of 3 Ply Surgical Masks in the United States
January 24, 2022 at 09:45 pm IST
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Control Print Limited is 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. 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.
Control Print Limited is an India-based company. The Company is engaged in manufacturing and supplying of coding and marking machines, its related consumables, and surgical / N95 Masks. Its products include continuous inkjet printer, high-resolution printer, thermal inkjet printer, thermal transfer over printer, laser printer, large character printer, consumables, surgical face mask, and N95 / FFP2 / IS 9473 Mask. The Company serves industries, such as Agrochemicals and Seeds, Automotive, Beverages, Building and Construction Material, Cable and Wire, Cement, Chemicals and Lubricants, Electronics, Food, FMCG, Healthcare, Packaging and Packaging Materials, Pipes and Extruded Plastics, Plywood, Rubber and Tyers, and Steel and Metal. It also produces coding and marking related consumables such as fluid ink, ink ribbons, and other essential supplies. Its subsidiaries include Liberty Chemicals Private Limited, Innovative Coding (India) Private Limited, and Control Print B. V., Netherlands.