All Medical Gloves comply with the European Standard EN455 Medical Gloves for Single Use. The standard is divided into 4 parts covering:
* Part1 Freedom from holes.
* Part2 Physical properties.
* Part3 Requirements for biological evaluation.
* Part4 Requirements and testing for shelf-life determination.
Our goal is to meet and exceed customer expectations. To ensure the highest level of quality, our products are subject to one of the most rigorous Quality Assurance regimes in the glove industry. To support this we operate a Quality Management System that is externally certified to ISO 9001.
We are committed to maintaining the highest levels of product quality, customer service, and ethical standards, whilst minimizing our impact on the environment. Our Environmental Management System is certified to ISO 14001 to allow us to continually assess and improve our environmental performance.
* Part 1 Requirements and Testing for Freedom From Holes
Gloves must pass this test in order to prove that they are an effective barrier against micro-organisms. A statistical sample taken from a batch of gloves is subject to checks for pinholes and leaks by filling with water. Gloves must achieve an acceptance quality limit (AQL) of 1.5 or better in order to be used as examination, procedure, or surgical gloves. AQL 1.5 is equivalent to a maximum risk of 1.5% that any given glove contains a pinhole capable of allowing water, and therefore micro-organisms, through the film.
* Part 2 Requirements and Testing for Physical Properties
This standard includes tests for glove dimensions and physical strength. The requirements for physical properties depend on the glove classification (surgical/examination) and material (Latex, Nitrile, Vinyl, Polythene).
* Part 3 Requirements and Testing for Biological Evaluation
This standard includes tests for potentially hazardous materials that may affect the wearer or be transferred to a patient. These materials include:
（1）Endotoxins: Toxic materials left behind by certain bacteria that can cause fever in humans (sterile gloves only)
（2）Latex Proteins: Because natural rubber latex is a natural product it contains proteins and enzymes that can cause a severe allergic reaction in genetically predisposed people (type I allergy)
（3）Chemical Residues: Most commonly, accelerators are used in the manufacture of the product itself. These can cause allergic dermatitis in some genetically predisposed individuals(type IV allergy) The materials above are tested individually as well as collectively, through the use of limited animal testing according to a separate standard, ISO10993
（4）Powder: A powder-free medical glove should have a powder level of <2mg per glove EN455 Medical Gloves for Single Use.
* Part 4 Determination of Shelf Life
This standard requires a complicated network of tests to determine how long a glove will be fit for use when stored in warehouses or in end-user storerooms. All calculations based on this testing must be checked by comparison to samples aged in real-time as soon as those samples become available. The maximum shelf-life that can ever be claimed for medical gloves is five years from the date of manufacture.
