BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Disposable Medical Face Mask

    K Number: K252650 · Decision Jan 5, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    4
    Review Days
    136

    Basic Information

    Device Name
    Disposable Medical Face Mask
    K Number
    K252650
    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
    Makrite Industries, Inc.
    Date Received
    August 22, 2025
    Decision Date
    January 5, 2026
    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 Makrite Industries, Inc.

    K Number Device Name
    K240258 Disposable Medical Face Mask (M643BE)
    K220550 Disposable Surgical Face Mask (M663BE, M663BT)
    K020474 MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95