Period-Care B-Corp Callaly Announce FDA 510(k) Clearance of Their Tampliner
The company's 2-in-1 "next-gen" tampon is the first innovation in 90 years
Callaly, an innovative period care manufacturer that empowers people through improved products, standards and service, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Callaly Tampliner. The device is a novel period care product, and the first significant design improvement to the tampon in 90 years.
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Callaly's award-winning tampliner (Photo: Business Wire)
The Tampliner, which is designed and manufactured in the UK and launched in February 2020, was invented by Dr Alex Hooi, a senior British gynaecologist and Fellow of the Royal College of Obstetricians and Gynaecologists and developed by garment technologist Ewa Radziwon, who trained at London College of Fashion. The product is protected by four granted patent families covering 80% of the $34bn global market. It is now being exported across Europe to Sweden, the Netherlands and Ireland.