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They can be used by medical professionals or individuals to protect the respiratory tract and mouth against potential infections. Thanks to low breathing resistance, they are comfortable during long work shifts. These masks are FDA and CE certified. They are also in
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FORLONG MEDICAL CO., LTD. Diamond Member. Audited Supplier. Wuxi, Jiangsu, China. Member Since:2010. Home Surgical Purfled High Elastic Bandage ISO CE FDA Approved. US $ 0.09-0.5/Piece Adjustable Medical Oxygen Venturi Mask with 7 Diluters --Ce &FDA.
Apr 01, 2011 · FDA has issued a letter for additional information, asking for a risk analysis document. The device, while Class II, is pretty basic and low tech (i.e. an oxygen mask). While we have experience with medical product design, engineering and manufacturing. None of us are too keen on risk analysis.
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