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

    Child Face Mask

    K Number: K201514 · Decision Oct 10, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    8
    Applicant Total
    3
    Review Days
    489

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Child Face Mask
    K Number
    K201514
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shandong Shengquan New Material Co., Ltd.
    Date Received
    June 8, 2020
    Decision Date
    October 10, 2021
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OXZ), ordered by most recent decision date.

    Kangbeier Child Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PRIMED Pediatric Facemask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Dukal Corporation Level 1 Pediatric Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    The iMask Child's Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Prestige Ameritech Pediatric/Child’s Face mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Shandong Shengquan New Material Co., Ltd.

    K Number Device Name
    K201629 Medical Face Mask
    K201537 Protective Face Mask for Medical Use