The BIS certification is intended to ensure product conformity in terms of quality, safety and reliability to the third parties in the Indian market. FDA 510 (k) clearance reflects that a particular product is both safe and effective for its intended use. While CE marking implies conformity of the goods with European standards of health, safety, and environmental protection, the U.S. ![]() 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. 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. ![]() 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. This product from Welspun India Ltd now has all required certifications to supply to the global markets including critical medical uses. This product was already certified by CE and Bureau of Indian Standards (BIS). Food and Drug Administration (FDA) 510 (k) clearance for its 3 Ply Surgical Masks. ![]() ![]() Welspun India Limited, a global leader in textiles, has now received one of the most stringent and most recognized quality approvals the U.S.
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