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Apr 07, 2020 · Surgical masks, including isolating masks, procedure masks, and dental masks, are classified as class II devices by the FDA. For these devices, manufacturers or importers are required to submit 501(k) premarket notification, and obtain FDA clearance, before placing the product in the market. Face Masks, Including Surgical Masks, and Respirators for Surgical masks:A mask that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks intended for medical purposes are considered Melt-blown Raw Material Quality Control Solutions for Face SGS has the experience to provide one-stop testing, inspection and certification solutions for surgical mask manufacturers, from examination of raw materials melt-blown fabric, through ISO 14644-1 cleanroom certification, and ISO 13485 management system certification
EC Type Examination Certification (Article 10) On-going Assessment of Compliance (Article 11) Factory Audit/ Compliance Testing ABOUT SGS Headquartered in Switzerland, SGS is the worlds leading inspection, verification, testing and certification company. Founded in 1878, SGS is recognised as the global benchmark in quality and integrity. SGS certification surgical mask Japan - Medical Face Masksoft SGS certification surgical mask Austria 3M Particulate Respirator 8210, N95 160 EA/Case 3M 3M Particulate Respirator 8210, N95 is a disposable particulate respirator that is designed to help provide reliable respiratory protection of at least 95 percent filtration efficiency against certain non . material SGS certification mouth muffle in Surgical Face and General-Use Masks Tests Nelson LabsTesting Locations. Salt Lake City, UT, USA; Study Outline. See individual test pages linked above for test specific study outlines. If you have additional questions about Surgical Face and General-Use Masks testing, or would like to consult with the experts at Nelson Labs, just send us a
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