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Face masks are usually divided into medical masks and protective respirators. US and EU requirements, medical masks (made in China) must meet the relevant standards (ASTM F2100 11 21 CFR 878.4040 & CE MDD 93/42/EEC EN14683:2014), the most important thing is to register the product locally (USDesignated US Agent + FDA Registration + FDA510K Premarket Notification, EUDesignated EU

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Considerations when using a surgical mask for suspected or confirmed cases. In the majority of situations where standard respiratory protection is needed, a single use surgical mask is appropriate (minimum Level 1 barrier). Refer to Appendix 2 for AS 43812015 Single use surgical face mask standard.

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