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510(k) Data Aggregation

    K Number
    K221209
    Device Name
    PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops
    Manufacturer
    Date Cleared
    2023-03-08

    (316 days)

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

    PADM Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended to be worn to protect both the patient and healthcare professional from transfer of microorganisms, body fluids, and particulate material. The PRECISION ECO™ Compostable / Plant Based Procedural Mask with Earloops is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, non-sterile, disposable device.
    Device Description
    The PRECISION ECO™ Compostable / Plant Based Procedural Masks with Earloops are single use, ASTM Level 3 disposable devices, provided non-sterile. The mask has a four-layer, flat, pleated body with two earloops and a malleable nose piece. All components of the mask design are bonded together via ultrasonic welding, and it does not include any drugs, biologics, or nanoparticles. The mask comes in one configuration with two (2) different color schemes: black (100195), and white (100196).
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    K Number
    K020510
    Device Name
    SMOKE EVACUATION HOSES/TUBING
    Manufacturer
    Date Cleared
    2002-05-03

    (77 days)

    Product Code
    Regulation Number
    878.5070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DM MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The smoke evacuation hoses are intended for the removal of smoke and particles generated from the point of surgical activity during a medical procedure that uses an electrosurgical pencil or laser for cutting and/or cauterizing. The are to be connected to a smoke evacuation unit securely on one end and the other end is to be held at the surgical site no farther than 2" from the point of lasering or cauterizing of tissue. They are a single use item, considered a bio-hazardous item after use in surgery, and must be disposed of after each case in a bio-hazardous bag (a red bag).
    Device Description
    A plastic smooth bore corrugated tubing with polyethylene adapters. Supplied in a variety of diameters and lengths. Also supplied in Sterile and Non-Sterile.
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