duoSHIELD™ gloves are dual registered as a Class 1 Medical Device (MDR) according to Regulation (EU) 2017/745 (Applicable norms are EN 455-1:2020, EN 455-2:2015, EN 455-3:2015 and EN 455-4:2009) and Personal Protective Equipment Category III (Complex Design) according to Regulation (EU) 2016/425.
duoSHIELD™ nitrile and latex gloves have been designed for general use in the laboratory (against minimal risks only) and for patient care activities.
duoSHIELD™ gloves are tested to demonstrate compliance with ISO 374-5:2016 for protection against biohazard. duoSHIELD™ gloves are microorganism resistant as demonstated by an Acceptable Quality Level (AQL) of 0.65 or 1.5 (in conformance with EN 455-1:2020 “Requirements and Testing for Freedom from holes” and ISO 374-2:2019 Level 2 or 3). duoSHIELD™ gloves are also virus resistant based on the viral penetration test (ISO 16604:2004 Procedure B).
The duoSHIELD™ range of powder-free natural rubber latex gloves contain 50µg/g or less of total water extractable protein based on the Modified Lowry Method (EN 455-3:2015 /
ASTM D5712-15 (2020)).