This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Harmonized
PUBLISHED
SRPS EN 455-1:2025
90.60
Close of review
Dec 2, 2025