BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Dukal Corporation Level 1 Pediatric Face Mask

    K Number: K210321 · Decision Mar 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    418

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    Basic Information

    Device Name
    Dukal Corporation Level 1 Pediatric Face Mask
    K Number
    K210321
    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
    Dukal Corporation
    Date Received
    February 4, 2021
    Decision Date
    March 29, 2022
    Product Code
    OXZ
    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
    OXZ Pediatric/Child Facemask

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    Other Clearances by Dukal Corporation

    K Number Device Name
    K212464 Dukal Corporation AAMI Level 4 Open-Back Protective Gown
    K203237 Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown
    K201732 Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On
    K201421 Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
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