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All our CE-marked cleanroom gloves are certified to comply with the requirements of the Personal Protective Equipment Regulation (PPER), (EU) 2016/425. Under the terms of the regulation our gloves are classed as Category III PPE. By CE marking our we claim that they satisfy the essential safety requirements of Regulation (EU) 2016/425 by the application of the following standards: EN 420:2003 +A1: 2009: Protective gloves – general requirements; EN 374-1: 2016: Protective gloves against dangerous chemicals and microorganisms – Part 1 Terminology and performance requirements for chemical risks; EN 374-2: 2015: Protective gloves against dangerous chemicals and microorganisms – Part 2 Determination of resistance to penetration; EN 374-4: 2013: Protective gloves against chemicals and microorganisms – Part 4 Determination of resistance to degradation by chemicals; EN 374-5: 2016: Protective gloves against dangerous chemicals and microorganisms – Part 5 Terminology and performance requirements for micro-organisms risks.
Our manufacturing process has five separate product inspections throughout. Each RAB/Isolator glove/Mitten is visually inspected 100% for holes, along with water and air pressure testing. This is achieved by the glove or mitten being filled with air to a specified pressure before being submerged underwater for three minutes. The water is checked for any bubbles identifying whether the product has a pinhole leak. This 100% inspection guarantees delivery of a glove or mitten free from holes, and is more rigorous than the AQL approach for surgical gloves which is based on a statistical sampling plan.
We have a comprehensive range of gloves suitable for use in this highly specialized area. Gloves tested against ASTM D6978-05 for a wide range of Cytotoxic drugs, recording excellent barrier performance under the ASTM defined permeation rates of 0.01µg/cm2/min, a level 100 times more stringent than that of EN 16523-1:2015. We will be pleased to supply further information on request.
Nitrile, vinyl and polychloroprene gloves are good for ESD properties. Latex gloves are not suitable if ESD properties are needed.