BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Biodegradable Medical surgical mask

    K Number: K231155 · Decision Nov 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    14
    Review Days
    197

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    Basic Information

    Device Name
    Biodegradable Medical surgical mask
    K Number
    K231155
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangdong Kingfa Sci. & Tech.Co., Ltd.
    Date Received
    April 24, 2023
    Decision Date
    November 7, 2023
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FXX Mask, Surgical

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    Other Clearances by Guangdong Kingfa Sci. & Tech.Co., Ltd.

    K Number Device Name
    K233723 Medical surgical mask
    K221983 Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
    K230046 Vinyl examination gloves
    K222612 Powder-Free Latex examination gloves
    K222714 Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
    K221887 Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color
    K213040 Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
    K213450 Medical surgical mask (Black mask, Level 1 and Level 3)
    K211220 Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
    K203593 Patient Examination Gloves
    Search all 14 clearances from Guangdong Kingfa Sci. & Tech.Co., Ltd. →