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

LONDON--(BUSINESS WIRE)--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.

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.

Callaly’s multiple-award winning Tampliner was recently recognised as a “next-gen tampon” in TIME’s 100 Best Inventions of 2020 - its annual list of the 100 Best Inventions that are making the world better, smarter and even a bit more fun.

Callaly’s founder and CEO, Thang Vo-Ta said: “We are excited that Callaly was able to receive 510K clearance from the US Food and Drug Administration, opening up the important US market for our Tampliner, now earmarked for launch in Summer 2021. We are committed to delivering innovative period care products that truly meet the needs of people with periods, through dedicated innovations that are highly differentiated and adhere to the highest possible standards.”

Image of the Tampliner can be found here.

ENDS

About Callaly:
Building on over 30 years of experience in gynaecology, Callaly is a commercial-stage period care manufacturer that is a certified B Corp- a for-profit company that’s committed to using business as a force for good. There are over 3,500 certified B Corps in the world including Patagonia, Danone, Allbirds and Unilever’s Ben & Jerry. Every decision Callaly makes, no matter how small, is taken with an eye on the wider global impact. Callaly donates at least 1% of sales to charities supporting women & children.

The privately held company has been supported with funding through the UK’s government’s innovation agency- Innovate UK, and employs 20 people in its London HQ. A wide range of high quality period care products are offered through its ISO9001 based Quality Management System including award-winning Tampliners, pantyliners, day pads, night pads and tampons. All products are offered in a range of different absorbencies and made with 100% organic cotton free from dioxins, perfumes, and pesticides. The Earth-friendly products are all wrapped in sustainable packaging.

Callaly has also developed new ways to manufacture and pack its period care products, with higher standards at the forefront whilst also using sustainable materials. Custom-made robotic systems as part of complete integrated machinery, have been developed and are subject to four further patent applications.