BRUSSELS - Novel Gloves First to be Classified as Class III Medical Devices
Ansell Healthcare, a global leader in healthcare barrier protection, announced today that it has received the CE Mark for GAMMEX® Powder-Free gloves with AMT Antimicrobial Technology. Through its unique virus and bacteria-killing technology, the novel GAMMEX Powder-Free with AMT provides protection against some of the most common pathogens and drug-resistant bacteria in the event of a glove breach*. Ansell will commercially launch GAMMEX Powder-Free gloves with AMT across Europe in the autumn of 2011.
"We look forward to bringing a new level of protection and peace of mind to the surgical staff," said Peter Dobbelsteijn, Senior Vice President EMEA, Ansell Healthcare. "GAMMEX Powder-Free with AMT has its own immune system to fight back against pathogens that migrate through the breaches that inevitably occur in actual use."
The gloves, made of natural rubber latex, provide the same feel, sensitivity, flexibility and dexterity as conventional gloves when manipulating and handling instruments. The main difference is the active antimicrobial layer which contains chlorhexidine gluconate (CHG). This proprietary technology can provide ongoing antiviral and antibacterial protection against HIV, hepatitis C and infectious bacteria.
"The new GAMMEX Powder-Free with AMT is a significant technical breakthrough in terms of bringing about a change from passive protection to active protection. These new gloves respond to the demands of healthcare workers in the surgical theatre who face infection risks every day. With AMT Antimicrobial Technology, we can offer healthcare workers an extra level of security. Glove breaches happen during surgery through the use of sharp instruments and with the AMT technology, Ansell provides for a backup plan," said David Lucas, Vice President Science & Technology, Ansell Healthcare.
Receiving the CE Mark is a major milestone in the process of bringing this groundbreaking technology to the European market.
* In clinical and laboratory tests, GAMMEX Powder-Free with AMT killed at least 99% of invading HIV and HCV (hepatitis C) surrogate pathogens, the two main viruses that concern surgeons. In addition, clinical testing has shown that the gloves kill over 99.7% of eight common infectious bacteria (gram-positive, gram-negative and drug-resistant bacteria) and kill over 99.99% of staphylococcus aureus.
GAMMEX Powder-Free Gloves with AMT Antimicrobial Technology are not proven to protect against blood-borne infections where the skin is broken, cut or punctured.
GAMMEX Powder-Free Gloves with AMT Antimicrobial Technology contain natural rubber latex, which may cause allergic reactions.
Australia Patent No. 703926 and New Zealand Patent No. 556353. AU and worldwide patents pending.
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Ansell is a world leader in providing superior health and safety protection solutions that enhance human well being. With operations in North America, Latin America, EMEA and Asia, Ansell employs more than 10,000 people worldwide and holds leading positions in the natural latex and synthetic polymer glove and condom markets. Ansell operates in four main business segments: Medical Solutions, Industrial Solutions, New Verticals and Sexual Wellness. Information on Ansell and its products can be found at www.ansell.eu
Source: Ansell Healthcare
Contact: Wouter Piepers, Global Communications - Ansell Tel: +322-5287400, +32-478335632; firstname.lastname@example.org