Vinyl 2000 PF Vinyl Examination Glove, Powder-Free

Standards and labels

• EN 455-2:2009

  Medical gloves with the EN 455-2:2009 rating are tested for their physical properties, such as strength, stretch, and dimensions. This ensures the gloves are durable and reliable, providing effective protection against cross-contamination for both the user and the patient.

  Test results

  Physical Properties Tested

  This glove has been tested for physical strength and durability to ensure it won't tear or break easily during use. It provides reliable protection from cross-contamination for both the wearer and the patient in medical situations.

• EN 455-1:1993

  Medical gloves for single use with the EN 455-1:1993 rating are tested for freedom from holes using a water leak test. This ensures the gloves provide an effective barrier against microorganisms and contamination, protecting both the user and others.

  Test results

  Tightness AQL #,##

  This product meets a quality standard for medical gloves, ensuring an extremely low chance of pinholes. It is tested for water tightness to protect you from cross-contamination during medical examinations, first aid, or other procedures requiring a reliable barrier.

• EN 455-4:2009

  Single-use medical gloves with the EN 455-4:2009 rating are tested for their shelf life, ensuring they maintain properties like strength and barrier integrity over time. This means the gloves will remain effective and safe, providing reliable protection against infections until their expiration date when stored correctly.

  Reach out to ask about the standard test results

• 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 455-3:1999

  Medical gloves with the EN 455-3:1999 rating are tested for biological safety, specifically evaluating levels of proteins and leachable substances. This ensures the gloves minimize potential allergic reactions and harmful effects for both the wearer and patient, providing peace of mind.

  Test results

  Biological Evaluation Tested

  This product has been tested for biological safety to ensure it is safe for skin contact. It minimizes the risk of adverse reactions from chemicals, latex proteins, and other residues used during manufacturing.

• MD Label

  MD stands for "Medical Device." It refers to any instruments, apparatus, machines, implants, or other similar or related articles that are intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability. In Europe, a MD Label is a special label that must be on all Medical Devices that are sold or used in the European Union (EU). The label must include information about the product, such as the name of the manufacturer, the intended use of the product and CE mark. To be able to sell or use a Medical Device in the EU, the device must meet certain standards and requirements set by the European Union and notified body.

• 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.