Welspun India Limited said it has become the first Indian company to receive 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 received all the required certifications to supply to global markets including critical medical uses.
Welspun’s 3 Ply Surgical Masks are made with 100 percent polypropylene and offer 98 percent protection against bacterial load, it said in a press release. 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 release said.
Dipali Goenka, Jt. MD & CEO of Welspun India 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. 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. The US PPE Market (including Medical PPE) is expected to grow to $24.3 bn by 2024, with respiratory protection products i.e. face masks being the fastest growing product.
