Welspun becomes 1st Indian firm to get US FDA approval for 3 ply surgical masks

Welspun India Limited announced on Monday that it has become the first firm in India to receive the US Food and Drug Administration (FDA) 510 (k) clearance for its 3 ply surgical masks. The 3 ply surgical masks are made with 100% polypropylene and offer 98% protection against bacterial load, as per Welspun India.

The BIS and CE certified product from Welspun India has now got all the required certifications to supply to global markets, including for critical medical uses, the company statement said.

The firm also stated that its WN-95 FFP 2 respiratory masks have been CE certified. This would enable Welspun to export the product to global markets, including Europe, AsiaPacific, Middle East, and Africa, amongst others.

Welspun India has received the clearances for both its products following due diligence including rigorous testing by the accredited test laboratories and review by respective regulatory authorities.

CE marking implies conformity of the WN-95 FFP 2 respiratory masks with European standards of health, safety, and environmental protection. While the US FDA 510K clearance reflects that a particular product is both safe and effective for its intended use, as per the firm's statement. Following these latest clearances, both masks can now be supplied in the international market.

Dipali Goenka, Jt MD & CEO of Welspun India Ltd, said, "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 channelise the momentum to further take the quality of healthcare products a notch higher at the global stage."

Earlier, Welspun had gained CE certification for a Half Face Respirator with Valve for increased COVID-19 protection.

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