Welspun becomes 1st Indian company to receive US FDA approval for surgical masks
By Sanjay Maurya
- Welspun announced that its 3 Ply Surgical Masks have received FDA 510 (k) clearance, making it the first Indian business to do so.
- Welspun’s 3 Ply Surgical Masks are manufactured from 100% polypropylene and offer 98 percent bacterial load control.
- The WN-95 FFP 2 Respiratory Masks have also been CE approved.
Welspun India Limited announced that its 3 Ply Surgical Masks have received FDA 510 (k) clearance, making it the first Indian business to do so. This product from Welspun India has previously been certified by BIS and CE and has gained all of the necessary certifications to be sold in worldwide markets, including critical medical uses.
Welspun’s 3 Ply Surgical Masks are manufactured from 100% polypropylene and offer 98 percent bacterial load control, according to a press statement. The WN-95 FFP 2 Respiratory Masks have also been CE approved, allowing for export to global markets such as Europe, Asia-Pacific, the Middle East, and Africa, according to the statement.
The two certifications were obtained after thorough testing of both products by recognized test facilities and review by the appropriate regulatory bodies. While CE marking indicates that the products fit with European health, safety, and environmental protection regulations, the US FDA 510K certification indicates that a product can be both safe and effective for its intended use, according to Welspun India’s statement to exchanges.
Both masks can available on the international market, thanks to recent clearances. The Company had previously received CE certification for a Half Face Respirator with Valve for greater Covid-19 protection, which had also been evaluated and verified by an international body, according to the company.
Welspun has always been at the forefront of innovation, working to set global standards for excellence. I am very pleased with Welspun India for being the first Indian company to receive FDA 510(k) clearance for their 3 Ply Surgical Masks. Welspun India’s Dipali Goenka, Jt. MD & CEO, said, this is terrific support of our idea of putting “people first” in everything we do, and we will use the momentum to raise the quality of healthcare products on a global scale.
WIL is a worldwide leader in home textiles and is a member of the Welspun Group, which has a market capitalization of $2.7 billion. It is Asia’s and the world’s largest terry towel maker, with 94 percent of its home textiles exported to more than 50 countries.
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