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510(k) Data Aggregation

    K Number
    K123115
    Device Name
    ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
    Manufacturer
    ACME FILTER MASK INC.
    Date Cleared
    2013-05-20

    (229 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACME FILTER MASK INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Face Mask of different colors (Blue, White, and Green) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of bacteria, body fluid and particulate material. This Surgical Face Mask is non-sterilized and disposable.
    Device Description
    Acme Filter Mask Inc. Surgical Face Mask with Ear-Loop is flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops. The nosepiece for all Acme Filter Mask Inc. Surgical Face Masks with Ear-Loop are malleable aluminum wire. All the materials used in the construction of the Acme Filter Mask Inc. Surgical Face Masks with Ear-Loop are being used in currently marked devices.
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