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510(k) Data Aggregation

    K Number
    K062663
    Device Name
    MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    Manufacturer
    MOLDEX/METRIC, INC.
    Date Cleared
    2006-10-11

    (34 days)

    Product Code
    MSH
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K061859,K051182
    Why did this record match?
    Reference Devices :

    K061859, K051182

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

    The various models of Moldex Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

    Device Description

    The Moldex type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown fitter media is layered between the inner and outer cover. The head straps are made of a non-latex rubber stapled to the mask, The inside nosepiece is a closed cell foam.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Moldex Health Care N95 Particulate Respirators and Surgical Masks, based on the provided text:

    Acceptance Criteria and Device Performance

    Performance CharacteristicsTest MethodAcceptance CriteriaReported Device Performance (Moldex Health Care N95 Particulate Respirators and Surgical Masks)
    Fluid Resistance PerformanceASTM 1862-00a32 of 32 pass32 of 32 pass
    Flammability Class16 CFR 1610Flame spread must be within upper and lower limits / Meets Class 1No flame spread on 10 of 10 samples, meets Class I
    Filter Efficiency (%)NIOSH, 42 CFR Part 84> 95% EfficientAverage 96.81% efficient of 20 samples
    Breathing Resistance (mm H₂O)NIOSH, 42 CFR Part 8495% efficiency when tested according to NIOSH 42 CFR Part 84.

    1. The sample size for the training set:
      Not applicable. This document describes the testing of finished products, not the development or training of an algorithm.

    2. How the ground truth for the training set was established:
      Not applicable. There is no algorithm training set discussed in this document.

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