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Home / Companies / News /  Welspun becomes first Indian firm to get US FDA nod for 3 ply surgical masks; shares surge

Welspun India on Monday announced that it has become the first Indian company to receive US FDA 510(k) approval for its 3 Ply Surgical Masks. Certified by BIS and CE already, the company said that this product from Welspun India Ltd has got all required certifications to supply to global markets including critical medical uses. Shares of Welspun India surged over 9% to 138 per share on the BSE.

The company said that its 3 Ply Surgical Masks are made with 100% polypropylene and offer 98% protection against bacterial load. Simultaneously, the WN-95 FFP 2 Respiratory Masks have been CE certified, enabling exports to global markets including Europe, AsiaPacific, Middle East, and Africa amongst others.

“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," Welspun India added in the communication to exchanges.

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, it added. 

“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," said Dipali Goenka, Jt. MD & CEO of Welspun India.

Welspun India Ltd (WIL), part of $2.7 billion Welspun Group, is a global leader in Home textiles.

 

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