Copolymed™ Individually Packaged Sterile Copolymer Examination Glove

Standards and labels

• EN ISO 11137

  Medical devices and healthcare products with the EN ISO 11137 rating are tested for the effectiveness of their radiation sterilization to ensure they are free from harmful microorganisms. This means consumers can trust that these products are safe and effective for use, greatly reducing the risk of infection.

  Reach out to ask about the standard test results

• EN ISO 13485:2016

  Medical devices with the EN ISO 13485:2016 rating are tested for their manufacturer's quality management system, covering product design, production, and related services. This ensures that these devices are consistently produced to be safe, effective, and meet strict regulatory requirements for your confidence and safety.

  Reach out to ask about the standard test results

• EN 455-1

  Medical gloves with the EN 455-1 rating are tested for freedom from holes to ensure they act as an effective barrier. This means the gloves reliably protect users and others from the transmission of microorganisms and contamination.

  Reach out to ask about the standard test results

• CE Marking

  CE Marking is a label that shows a product meets certain safety and environmental standards set by the European Union. To get the CE Marking, a company must test and certify their product meets these standards. CE Marking is required for many products sold in the EU, including electronics, machinery, toys and medical devices. It helps ensure that products are safe for consumers and the environment, and allows for easy trade within the EU.