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

    Procedure mask/Surgical mask/Face mask

    K Number: K250082 · Decision Jun 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    329
    Registration Numbers
    329
    Same Product Code
    598
    Applicant Total
    16
    Review Days
    156

    Basic Information

    Device Name
    Procedure mask/Surgical mask/Face mask
    K Number
    K250082
    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 13, 2025
    Decision Date
    June 18, 2025
    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.

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    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
    K221720 Extra Silver Gelling Fiber Dressing
    K221819 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown
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