Welspun India Limited, a global leader in textiles, has now received one of the most stringent and most recognized quality approvals; the U.S. Food and Drug Administration (FDA) 510 (k) clearance for its 3 Ply Surgical Masks. This product was already certified by CE and Bureau of Indian Standards (BIS). This product from Welspun India Ltd now has all required certifications to supply to the global markets including critical medical uses.

Its WN-95 FFP 2 Respiratory Masks have simultaneously been CE certified, which will allow export to global markets including Europe, Asia-Pacific and Africa, amongst others.

Last year, the company had emerged as the first Indian company to receive a similar certification from the BIS for its single-use PPE Covid coveralls.

The three clearances were received following due diligence including rigorous testing of these products by the accredited test laboratories and review by respective regulatory authorities. While CE marking implies conformity of the goods with European standards of health, safety, and environmental protection, the U.S. FDA 510 (k) clearance reflects that a particular product is both safe and effective for its intended use. The BIS certification is intended to ensure product conformity in terms of quality, safety and reliability to the third parties in the Indian market.

Welspun’s 3 Ply Surgical Masks are made with 100% polypropylene and offer 98% protection against bacterial load. On the other hand, the WN-95 FFP 2 Respiratory Masks offer optimal viral barrier performance and have previously received IS 9473 Accreditation along with the ISI symbol.

Welspun had earlier also gained CE certification for a Half Face Respirator with Valve for increased Covid-19 protection, which was also tested and verified by an international agency.
Welspun Health’s manufacturing facility is certified as per stringent quality management system for medical devices ISO: 13485 by BSI – British Standards Institution.