EN 455 – standard relating to single use medical gloves

Part 1: Requirements and testing for freedom from holes.

This standard specifies the test method for single use medical gloves in order to determine freedom from holes. In order for gloves to be considered a medical device the compliance level for freedom from holes must be an Acceptable Quality Level - AQL of 1.5.

Part 2: Requirements and testing for physical properties.

This standard specifies test methods for physical properties of single use medical gloves.

It stipulates the requirements which need to be met in order to ensure that the gloves provide and maintain in use an adequate level of protection from cross contamination for both patient and user.

This standard sets forth median length and width [mm] as well as medians of force at break [N] for surgical and examination gloves made of diverse raw materials: latex, nitrile or elastomers.

Part 3: Requirements and testing for biological evaluation.

This standard specifies requirements for the evaluation of biological safety for single use medical gloves.

Requirements for labelling and packaging as well as disclosure of information relevant to the test methods used

• Information requirements for latex gloves:
  - The packaging must contain information on possible allergic reactions including anaphylactic reaction.
  - There must be a pictogram “LATEX” (triangle-shaped sign with the word “LATEX” within) on the packaging of latex gloves.
• Review of immunological test methods aiming at labelling leachable proteins and allergens (leachable latex proteins and endotoxins).
• The standard defines powder-free gloves as the ones with powder level of <2mg per glove.

The standard further specifies that on the packaging of latex gloves there should be no information or terms suggesting relative safety of usage i.e. low allergenicity, hypoallerginicity or low protein content.

The standard does not provide for the latex protein levels which should be reached during latex gloves tests.
Neither does the norm define a glove which does not cause allergies.

Part 4: Requirements and testing for shelf life determination.

This standard specifies the requirements and test method for single use medical gloves in order to determine shelf life of the product pursuant to Medical Devices Directive 93/42/EEC.

EN 374 - This standard specifies the capability of gloves to protect the user against chemicals and/or micro-organisms.

It enumerates chemical substances and their concentration for chemical resistance test of the gloves.
The standard lists the pictograms which are to be used for fully protective gloves and gloves of limited protection from chemicals.
A glove protecting from chemicals which has the second level of penetration (<AQL 1.5) at G1 inspection level (air and water leak test) also protects from bacteria and mould.

EN 420 – protective gloves – general requirements and test methods

This standard defines general requirements for protective gloves (among others: size, dexterity, PH) as well as labelling and information to be provided by the producer.

EN 388 - gloves protecting from mechanical risks

The standard stipulates requirements as well as test and labelling methods for all kinds of protective gloves in terms of resistance to physical and mechanical actions such as heavy rubbing, cutting, puncture and tearing.

ASTM F 1671 – Viral Penetration Test

An American standard which defines test method for the resistance of materials to penetration by blood-borne pathogens using Phi-X174 bacteriophage as a test system.

ASTM D6978-05

An American standard specifying the methods for assessment of resistance of medical gloves to permeation by cytostatic drugs.