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510(k) Data Aggregation

    K Number
    K971744
    Device Name
    FLOOR MASK-EAR LOOP(BMR-15011)/FLOOR MASK-TIE(BMR-1503)
    Manufacturer
    BERKLEY MEDICAL RESOURCES, INC.
    Date Cleared
    1997-07-28

    (77 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BMR - 1501, 1503 Surgical Face Mask is a surgical apparel device that is intended to be worn by operating personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of micro-organisms. body fluids, and particulate material. The BMR - 1501, 1503 Surgical Face Mask is intended to be used in the above application as a single use disposable device.

    Device Description

    Surgical Face Mask, Code 1501, 1503

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a surgical face mask (BMR-1501, BMR-1503). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested information. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, and the specific performance data and acceptance criteria are typically part of the submission materials rather than the clearance letter itself.

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