The SMARTLine™ nitrile gloves are dual registered as a Class 1 Medical Device (MDR) according to Regulation (EU) 2017/745 and Personal Protective Equipment Category III (Complex Design) according to Regulation (EU) 2016/425.
The SMARTLine™ nitrile gloves have been designed for all applications requiring a general protection.
The SMARTLine ™ nitrile gloves offer an excellent compromise between optimal quality and cost, thereby providing a solution for personnel seeking protection against limited risks. The SMARTLine™ gloves are tested to demonstrate compliance with ISO 374-5:2016 for protection against biohazard. The SMARTLine™ gloves are microorganism resistant as demonstrated by an Acceptable Quality Level (AQL) of 1.5 (in conformance with EN 455-1:2000 “Requirements and Testing for Freedom from holes” and ISO 374-2:2019 Level 2). The SMARTLine™ gloves are also virus resistant based on the viral penetration test (ISO 16604:2004 Procedure B). The SMARTLine ™ gloves are tested for chemical permeation according to ISO 374-1:2016+A1:2018 (Test method EN 16523-1:2015+A1:2018).