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Regulations for the Supervision and Administration of Medical Devices: YY/T 0969-2013: Surgical Mask: YY 0469-2011: EU: Type I Type II Type IIR: Directive 93/42/EEC: EN 14683-2019+AC:2019 : United States: Level 1 Level 2 Level 3: 21 CFR Subchapter H: ASTM F2100-19: Marking United States Classified as Class 2 medical device in the US medical masks must meet the labeling requirements

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Mask for medical use shall be able to resist liquid penetration N95 respirators cleared by both NIOSH and FDS are frequently referred to as medical respirators healthcare respirators or surgical N95s2 3 European Union (EU) In EU respirators are regulated by the Personal Protective Equipment Regulation (REGULATION (EU) 2016/425) Its corresponding harmonized standard is EN149 The standard