Welspun India, India’s major home textiles company, has received approval from the US health regulator for its 3 ply surgical masks.
The company claims that it has become the first Indian company to receive the US Food and Drug Administration (USFDA) 510K, one of the stringent and most recognised quality approvals, for its 3 ply surgical masks.
The company said, “Certified by BIS and CE already, this product from Welspun India Ltd. has got all required certifications to supply to global markets including critical medical uses.
Welspun’s 3 ply surgical masks are made with 100 per cent polypropylene and offer 98 per cent protection against bacterial load. “This is one of the tedious pre-market submissions made to FDA to demonstrate that the medical device to be marketed is as safe and effective,” it added.
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.
“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,” said Dipali Goenka, JMD & CEO of the company.
The company also said that while CE marking implies the conformity of the goods with European standards of health, safety, and environmental protection, the USFDA 510K clearance reflects that a particular product is both safe and effective for its intended use. Following the latest clearances, both masks can be supplied in the international market.