At SURGISYL, we put our face masks through multiple testings to ensure premium quality. Surgical masks made at our manufacturing facility in Singapore have met EN 14683 Type IIR European Standards and are certified as Medical Grade with > 99% Bacterial Filtration Efficiency (BFE) & Particulate Filtration Efficiency (PFE).
SURGISYL Masks are registered with the U.S. Food and Drug Administration (FDA) under the operator number 10078028.
FDA Device Classification Name: FACE MASK FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE.
Below are a list of test reports and certifications that SURGISYL masks have received:
HSA License: ES0501141