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

    Procedure mask/Surgical mask/Face mask

    K Number: K220194 · Decision May 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    18
    Review Days
    113

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    Basic Information

    Device Name
    Procedure mask/Surgical mask/Face mask
    K Number
    K220194
    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
    Winner Medical Co., Ltd.
    Date Received
    January 24, 2022
    Decision Date
    May 17, 2022
    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 Winner Medical Co., Ltd.

    K Number Device Name
    K252001 Collagen Wound Dressing
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    K231057 Antibacterial Gel Wound Dressing
    K231564 Skin and Wound Cleanser
    K231152 Collagen Wound Dressing
    K221311 Antibacterial Bandage
    K223232 Procedure mask/Surgical mask/Face mask
    K221532 PHMB Wound Dressing
    K221754 Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
    K221755 Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
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