Yanimed Achieves ASTM Medical Standards, Looks to Expand Footprint in the US
Yanimed has recently achieved the ASTM D6319-19 standards and submitted the 510k application. These developments are critical to the brand’s ambitious expansion plans in the US.
NEW YORK, March 08, 2021 (GLOBE NEWSWIRE) -- Yanimed is pleased to announce that it has recently achieved the medical device standards as laid down by the American Society for Testing and Materials (ASTM). These standards specify and evaluate the design and performance requirements for different biomedical materials, tools, and equipment in the United States. A Malta-based brand delivering world-class nitrile gloves and protective masks, Yanimed has also submitted the 510k application with the goal of conducting long term business operations in America in the aftermath of the Covid-19 pandemic.
Comprising of over 30,000 volunteer members from more than 140 countries, the ASTM is a global leader in the development of voluntary consensus standards used by individuals, companies, and other institutions around the world. They develop and publish technical standards for many different industries with the goal of enhancing performance and safety over a wide range of products, materials, systems, and services.
The specific requirements for nitrile rubber gloves used in medical testing, diagnosis and treatment are described under the standard ASTM D6319-19. This standard applies to handmade gloves; examination gloves made of nitrile rubber, as well as packaged sterile or non-sterile or non-sterile bulk examination gloves made of nitrile rubber. It also provides test methods to evaluate the performance and safety of nitrile rubber gloves manufactured for medical examinations and diagnostic and treatment procedures. By achieving this standard, Yanimed has established the fact that its nitrile gloves are tested and qualified.
In the pre-Covid US market, almost any company could ell medical devices, gloves, and other protective gears. However, after the pandemic, the 510k certification plays critical role in this process. Technically speaking, 510(k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. It contains detailed technical, safety, and performance information about a medical device. The documentation must demonstrate the device in question is "substantially equivalent" to a predicate device. The 510(k) applications must be reviewed and cleared by the FDA before the applicant legally sell or distribute its products in the US.
"Our collective understanding of COVID-19 has greatly expanded since the start of the pandemic, as well as how to protect ourselves," said Sergio Raygada, CEO US Operations, Yanimed. “Our nitrile gloves are latex-free examination gloves, well tolerated by the skin and powder-free. Having achieved the ASTM standards, we are confident about making a positive impact on the US market.”
Some salient features of Yanimed nitrile gloves include:
To find out more about Yanimed nitrile gloves, please visit https://yanimed.com/
About Yanimed: Yanimed is a brand of Blokkx Ltd. based in Malta. Under the brand-name Yanimed, the company produces protective articles like nitrile gloves and protective masks. All its products are manufactured in selected factories in Asia, mainly from Vietnam, China, Thailand and Malaysia that meet stringent quality standards.
Phone: + 44 330 02 7 02 07
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/311b7be0-dd14-4138-9b7b-a82f04bdac36
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