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510(k) Data Aggregation

    K Number
    K063023
    Device Name
    3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
    Manufacturer
    3M COMPANY
    Date Cleared
    2007-02-23

    (144 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product meets CDC guidelines for M. tuberculosis exposure control. As a This product incels ODO galdemiseace wearer exposure to certain airborne particles including those generated by electrocautery, laser surgery, and other powered medical instruments. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials.

    Device Description

    Not Found

    AI/ML Overview

    This document (a 510(k) clearance letter) describes the clearance of a 3M N95 Health Care Particulate Respirator and Surgical Mask. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain the detailed information necessary to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

    Here's why and what information is missing:

    • Acceptance Criteria and Reported Device Performance: This letter only states that the device "meets CDC guidelines for M. tuberculosis exposure control" and is "fluid resistant to splash and spatter of blood and other infectious materials." It does not provide a table with specific numerical acceptance criteria (e.g., filtration efficiency percentage, fluid resistance mmHg) or the corresponding reported device performance values.
    • Study Design Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Data): The letter does not describe any specific study's methodology, results, or ground truth establishment. It refers to the 510(k) premarket notification (K063023), which would contain the detailed technical data and performance studies. The letter is the outcome of the FDA's review of that submission, not the submission itself.

    To answer your questions fully, one would need to access the full 510(k) submission for K063023, which is typically a much more extensive document.

    Therefore, I cannot provide the requested table and detailed study information based solely on the provided text.

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