Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K063747
    Device Name
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS, MODELS MFRN95-S, MFRN95-XS, MFRN95-ML, MFRN95-A
    Manufacturer
    INOVEL LLC
    Date Cleared
    2007-01-12

    (24 days)

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

    INOVEL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The various models of Inovel 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 Inovel 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 filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.
    Ask a Question
    K Number
    K062665
    Device Name
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    Manufacturer
    INOVEL LLC
    Date Cleared
    2006-10-24

    (47 days)

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

    INOVEL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The various models of Inovel 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 Inovel 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 filter media is lavered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.
    Ask a Question
    K Number
    K061859
    Device Name
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS & SURGICAL MASKS
    Manufacturer
    INOVEL LLC
    Date Cleared
    2006-07-12

    (12 days)

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

    INOVEL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The various models of Inovel 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 Inovel 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 filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.
    Ask a Question
    K Number
    K051182
    Device Name
    INOVEL HEALTH CARE MODEL N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
    Manufacturer
    INOVEL LLC
    Date Cleared
    2005-05-19

    (10 days)

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

    INOVEL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The various models of Inovel/Cardinal 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 Inovel type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask (for double headband) and polyester elastic (for single head strap) which is sewn to the mask. The inside nosepiece is a closed cell foam.
    Ask a Question
    K Number
    K042267
    Device Name
    INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
    Manufacturer
    INOVEL LLC
    Date Cleared
    2004-09-30

    (38 days)

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

    INOVEL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1