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510(k) Data Aggregation

    K Number
    K964722
    Device Name
    DELTA N95 RESPIRATOR
    Date Cleared
    1997-02-07

    (74 days)

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

    RACAL FILTER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Delta N95 Respirator and Surgical Mask will be used for the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CIX' TB Prevention Guidelines.
    Device Description
    DELTA N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory protective device. This disposable Surgicul mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner serim hayer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer, outer scrim layer and clastic band. DELTA N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #TC-84A-0003) and has a filtration efficiency level of 95% and is effective against particulate acrosols free of oil. DELTA N95 RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, small, medium and large. The nose clip and elustic headband ensures effective face to mask seal.
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    K Number
    K964723
    Device Name
    RACAL N95 RESIRATOR
    Date Cleared
    1997-02-07

    (74 days)

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

    RACAL FILTER TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Racal N95 Respirator and Surgical Mask will be used for the health care practitioner from blood and body fluids and particulates and to meet the NIOSH / CDC TB Prevention Guidelines.
    Device Description
    RACAL N95 RESPIRATOR AND SURGICAL MASK is indicated for respiratory proceetive device. This disposable Surgical mask is a one-piece, light weight half mask with filter material forming the mask. The component includes an inner scrim layer, netting material forming the mask. The component includes an inner scrim layer, netting layer, meltblown protection layer and elastic band. RACAL N95 RESPIRATOR AND SURGICAL MASK is NIOSH approved (Approval #IC-84A-0008) and has a filtration efficiency level of 95% and is effective against particulate aerosols free of oil. RACAL NYS RESPIRATOR AND SURGICAL MASK is available in four sizes, extra small, medium and large, The nose clip and elastic headband ensures effective face to mask seal.
    Ask a Question

    Ask a specific question about this device

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