Welspun, first Indian Company to receive US FDA 510(k) for its 3 Ply Surgical Masks

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Welspun India Limited, the global leader in home textiles, has now become the first Indian company to receive one of the stringent and most recognized quality approval i.e. US Food and Drug Administration (FDA) 510 (k) clearance for its 3 Ply Surgical Masks. Certified by BIS and CE already, this product from Welspun India Ltd has got all required
certifications to supply to global markets including critical medical uses.

Welspun’s 3 Ply Surgical Masks are made with 100% polypropylene and offer 98% protection against bacterial load. This is one of the tedious premarket submissions made to FDA to demonstrate that the Medical device to be marketed is as safe and effective. Simultaneously, the WN-95 FFP 2 Respiratory Masks have been CE certified, enabling exports to global markets including Europe, Asia-Pacific, Middle East, and Africa amongst others. . The WN-95 FFP 2 Respiratory Masks offer optimal viral barrier performance and have previously received IS 9473 Accreditation along with the ISI symbol. The two clearances were received following due diligence including rigorous testing of both products by the accredited test laboratories and review by respective regulatory authorities. While CE marking implies conformity of the goods with European standards of health, safety, and environmental protection, the US FDA 510K clearance reflects that a particular product is both safe and effective for its intended use.

Speaking on this, Ms. Dipali Goenka, Jt. MD & CEO of Welspun India Ltd commented, “Welspun has always pioneered innovation and aimed to set global benchmarks for excellence. I am delighted that Welspun India is the first Indian Company to receive US FDA 510(k) clearance for its 3 Ply Surgical Masks. This is a remarkable validation of our philosophy of keeping ‘people ahead of everything’ and we will channelize the momentum to further take the quality of healthcare products a notch higher at the global stage.”

Following the latest clearances, both masks can be supplied in the international market. Welspun had earlier also gained CE certification for a Half Face Respirator with Valve for increased Covid-19 protection, which was also tested and verified by an international agency. Welspun Health manufacturing facility is certified as per stringent quality management system for medical devices ISO: 13485 by British Standards Institution. The US PPE Market (including Medical PPE) is expected to grow to US $ 24.3 bn by 2024, with the Respiratory Protection products i.e. Face Masks being the fastest growing product. Welspun India, one of the few manufacturers of Masks with International
certifications, is poised to be a part of the global PPE supply chain.

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