Exam gloves cerificates


Exam gloves used in hospitals should have a product class designation and CE certification and assessment of conformity according to European standards. Pictograms referring to gloves as PPE are placed on the glove box. These are the standards EN ISO 374-1 to EN ISO 374-5.

Exam gloves standards as personal protective equipment in accordance with Regulation (EU) No 2016/425:
EN ISO 21420 (replaces EN 420) general requirements, relevant glove testing and marking procedures, and information provided by the manufacturer. The standard does not address protective properties and should be used in conjunction with other standards.
Standards related to chemical and biological resistance: EN ISO 374-1 Protective gloves against hazardous chemicals and microorganisms. Part 1: Terminology and performance requirements for chemical risks
EN ISO 374-2 Protective gloves against hazardous chemicals and microorganisms. Part 2: Determination of resistance to penetration
EN 16523-1 Replaces EN 374-3 Determination of resistance of materials to permeation by chemicals. Part 1: Permeation of potentially hazardous liquid chemicals under continuous contact conditions
EN ISO 374-4 Protective gloves against hazardous chemicals and micro-organisms. Part 4: Determination of resistance to degradation by chemicals

EN ISO 374-5 Protective exam gloves against hazardous chemicals and micro-organisms. Part 5: Terminology and requirements for risk of transmission of microorganisms
Standards for medical gloves as a medical device complying with Regulation (EU) No 2017/745:
EN 455-1 Medical gloves for single use. Part 1: Requirements and testing for absence of holes
EN 455-2 Medical gloves for single use. Part 2: Requirements and testing for physical properties
EN 455-3 Medical gloves for single use. Part 3: Requirements and testing for biological evaluation
EN 455-4 Medical gloves for single use. Part 4: Requirements and testing for shelf life determination

Links for research and certification units


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