Rexam Healthcare Receives 510(k) FDA Approval
Rexam Healthcare recently announced it has received 510(k) approval from the Food and Drug Administration (FDA) for Safe’n’Sound, its passive safety device for staked prefilled syringes. The approval is the crowning achievement of significant investment and efforts in terms of design by the Rexam teams.
The aim of the project was to design a safety device that meets the current regulations in North America and in
The fully passive Safe’n’Sound device provides effective protection against the risks of being pricked by a soiled needle, due to the protective sheath that activates automatically once the medicine has been administered. This 510(k) approval shows Rexam’s commitment to innovation, safety, and quality and allows the product to be marketed in the
Rexam is a leading global consumer packaging company. It is one of the leading global beverage can makers and a major global player in rigid plastic packaging. Rexam is business partners to some of the world’s most famous and successful consumer brands. Its vision is to be the best global consumer packaging company. Rexam Healthcare provides solutions to protect and deliver pharmaceuticals. Building on its core expertise in plastic injection, injection blow-moulding, and high-speed automated assembly, it designs, develops, and manufactures innovative packaging, including containers and closures, drug delivery devices, metering pumps and valvess and medical components to improve patients’ health. Completely focused on healthcare, the company relies on its regulatory knowledge to support its customers and manufacture in strict compliance with GMPs to meet the highest standards of quality, safety, and consistency.
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