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Tuesday, 07 September 2021 16:22

Welspun India receives USFDA 510 (k) approval for 3 ply surgical masks

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Welspun India has received USFDA 510(k) approval for its 3 ply surgical masks. Certified by BIS and CE, these masks from Welspun India have received 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. Similarly, the company’s WN-95 FFP 2 respiratory masks are CE certified, and can be exported to all global markets including Europe, AsiaPacific, Middle East, and Africa, etc.

The CE marking implies conformity of the goods with European standards of health, safety, and environmental protection, while the US FDA 510K clearance reflects that product adheres to all the required safety and quality standards. Following the latest clearances, both masks can be supplied in the international market. 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.