Welspun India secures FDA 510 (k) clearance for 3 Ply Surgical Masks

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Welspun India Limited, a Mumbai-based home textile company, has secured 510 (k) clearance from the US Food and Drug Administration (FDA) for its 3 Ply Surgical Masks.

The product, which is also certified by BIS and CE, has all the necessary certifications to supply to global markets, including critical medical uses, said Welspun India.

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The 3 Ply Surgical Masks are said to be made with 100% polypropylene and provide 98% protection against bacterial load.

The Indian textile company said that simultaneously its WN-95 FFP 2 Respiratory Masks have been CE certified, thereby allowing their exports to global markets.

Welspun India secures FDA 510 (k) clearance for 3 Ply Surgical Masks

Welspun India secures FDA 510 (k) clearance for 3 Ply Surgical Masks. Photo courtesy of Welspun.

According to Welspun India, the WN-95 FFP 2 Respiratory Masks provide optimal viral barrier performance and had previously secured IS 9473 accreditation along with the ISI symbol.

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Dipali Goenka — Jt. MD and CEO of Welspun India said: “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.”

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