Santex Vinyl Gloves, Blue

Standards and labels

• ISO 13485:2016

  Medical devices with the ISO 13485:2016 rating are tested for a quality management system that ensures consistent safety, quality, and regulatory compliance throughout their lifecycle. This provides assurance that the product is reliably produced to high international standards for patient use.

  Test results

  Medical Management Passed

  This product was made under a quality management system that ensures consistent design, production, and distribution. This focuses on the safety, performance, and regulatory compliance of medical devices throughout their entire lifecycle, from design to disposal.

• EN ISO 374-1:2016

  Gloves with the EN ISO 374-1:2016 rating are tested for resistance against dangerous chemicals and microorganisms, including penetration, permeation, and degradation. This means you can choose gloves designed to protect your hands from specific chemical hazards, ensuring safer use in various tasks.

  Reach out to ask about the standard test results

• EN 374-5:2016

  Gloves with the EN 374-5:2016 rating are tested for resistance to penetration by bacteria and fungi, and potentially viruses. This means the gloves provide a protective barrier against microorganisms, helping to keep your hands safe from harmful biological agents.

  Test results

  Micro-organisms Virus

  This glove is tested to protect you from bacteria, fungi, and viruses. It provides a reliable barrier, having passed specific tests to ensure no leakage when exposed to these micro-organisms, making it suitable for handling contaminated materials.

• EN 374-2:1994

  Gloves with the EN 374-2:1994 rating are tested for resistance to penetration by dangerous chemicals and microorganisms. This means the gloves prevent liquids from seeping through tiny holes or imperfections, ensuring your hands are protected.

  Test results

  Penetration Resistance Tested

  This glove protects against leaks of chemicals and microorganisms. It has passed an air and water leak test to ensure it is a waterproof and effective barrier, making it suitable for tasks like cleaning or handling biological materials.

• EN 420:2003+A1:2009

  Protective gloves with the EN 420:2003+A1:2009 rating are tested for general design, safe materials (innocuousness), water penetration, comfort, and dexterity. This ensures the gloves are safe, fit correctly, and allow you to perform tasks effectively without discomfort.

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• EN 455-2

  Medical gloves with the EN 455-2 rating are tested for physical properties like dimensions and strength, including force at break both before and after aging. This ensures the gloves fit correctly, are durable, and provide reliable protection against cross-contamination for both patient and user.

  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.

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• EN 1186-7:2002

  Plastic films and sheets used in food packaging with the EN 1186-7:2002 rating are tested for overall migration of chemical substances into water-based foods. This ensures the plastic material does not transfer harmful substances into your food, protecting your health and the quality of your food.

  Reach out to ask about the standard test results

• EN 16523-1:2015

  Protective clothing, gloves, and footwear materials with the EN 16523-1:2015 rating are tested for resistance to permeation by hazardous liquid chemicals, specifically how long it takes for a chemical to pass through the material. This ensures the product provides a dependable barrier, offering a measurable level of safety when handling dangerous liquids.

  Test results

  Permeation Contact Tested

  This product’s material resists liquid chemical breakthrough. It is tested for how long it takes a chemical to move through the material on a molecular level, offering protection for a specified time during continuous contact.

• EN 455-3

  Single-use medical gloves with the EN 455-3 rating are tested for biological safety, including potential chemical residues, latex proteins, and powder content. This ensures the gloves are safe for skin contact, minimizing the risk of irritation or allergic reactions for users and patients.

  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.

• Food Safe

  Food safe refers to the safety of food products that are used or consumed by people. In Europe, food safety is regulated by the European Union (EU) and the European Food Safety Authority (EFSA). These organizations set standards and requirements for food products to ensure they are safe to eat. To be considered "food safe" in Europe, a product must meet these standards and be free of harmful substances. This includes being free of harmful bacteria, pesticides, and other contaminants. Food products that do not meet these standards cannot be sold or used in the EU.

• PPE Category 3

  PPE stands for "personal protective equipment." PPE Category 3 refers to equipment that is complex and provide the highest level of protection such as powered respirators, SCBA, and full body suits. In Europe, PPE Category 3 must meet certain safety standards set by the European Union, which means that it must be designed and manufactured to protect the user without causing harm. Companies that make or sell PPE must prove that it meets these standards. They also must have a quality management system in place, have to be audited regularly by a notified body and have to have a technical documentation.