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

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.

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. 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.

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.”