Welspun India becomes first Indian company to receive USFDA 510(k) clearance for 3 Ply Surgical Masks

06 Sep 2021 Evaluate

Welspun India has now become the first Indian company to receive one of the stringent and most recognized quality approval i.e. US Food and Drug Administration (FDA) 510 (k) clearance for its 3 Ply Surgical Masks. Certified by BIS and CE already, this product from Welspun India has got all required certifications to supply to global markets including critical medical uses.

Welspun’s 3 Ply Surgical Masks are made with 100% polypropylene and offer 98% protection against bacterial load. This is one of the tedious premarket submissions made to FDA to demonstrate that the Medical device to be marketed is as safe and effective. Simultaneously, the WN-95 FFP 2 Respiratory Masks have been CE certified, enabling exports to global markets including Europe, AsiaPacific, Middle East, and Africa amongst others.

Welspun India is one of the largest manufacturers and exporters of bed & bath textile products globally. The company’s portfolio comprises wide range of home textile products such as terry towels, bed linen (basic bedding and decorative bedding) rugs and bathrobes.

Welspun Living Share Price

135.75 -1.45 (-1.06%)
15-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Welspun Living 135.75
Vardhman Textiles 449.90
Arvind 321.80
K.P.R. Mill 969.90
Page Industries 36772.25
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