Loxtay FXX Series Products complies with the essential safety and health requirements of the Medical Devices Directive 93/42/EEC–General Product Safety Directive 2001/95/EEC. The product is attested against: EN 14683+AC, EN 1041+A1, EN ISO 13485, EN ISO 14971, EN ISO 10993-1, EN ISO 10993-10, EN ISO 15223-… Continue reading
This directory contains Mask related information. It shows of Loxtay products and Certification Body explantions and notes, International standards and product related informations and short notices.
What is Surgical Mask (Face Mask)? A surgical mask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Surgical masks are regulated under 21 CFR 878.4040. Surgical masks are not to be shared and may be labeled as surgical, … Continue reading
EN 14683:2005 Mask Classifier Standart This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infectivea gents from staff to patients and (in certain situations vice;versa) during surgical procedures in operating theatres and other medical settings with similar requirements. This European Standard is not applicable … Continue reading
Below is the PDF Catalogue for 3 Ply Masks. As FDA is not classifying Surgical masks to Levels. European standards EN 14683:2005 is used to define the types of the products. The PDF file hosts the following type of products: Type I Products Type IR Products Type II Products Type IIR Products Also youcan select … Continue reading