Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K053441
    Device Name
    BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
    Manufacturer
    REGENT MEDICAL AMERICAS, LLC
    Date Cleared
    2006-04-10

    (122 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGENT MEDICAL AMERICAS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Biogel Latex Sterile Powder-Free Surgeon's Glove with Low Dermatitis Potential and Protein Content Labeling Claim (50 micrograms or less)
    Ask a Question
    K Number
    K053102
    Device Name
    BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
    Manufacturer
    REGENT MEDICAL AMERICAS, LLC
    Date Cleared
    2006-03-10

    (126 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGENT MEDICAL AMERICAS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of Non-latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Non-latex sterile powder-free surgeon's glove
    Ask a Question
    K Number
    K053442
    Device Name
    BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
    Manufacturer
    REGENT MEDICAL AMERICAS, LLC
    Date Cleared
    2006-03-07

    (88 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGENT MEDICAL AMERICAS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Poly-Isoprene non-latex sterile powder-free surgeon's glove with Non-pyrogenic statement
    Ask a Question
    K Number
    K053443
    Device Name
    BIOGEL ECLIPSE NON-PYROGENIC LATEX POWDER-FREE STERILE SURGEON'S GLOVE
    Manufacturer
    REGENT MEDICAL AMERICAS, LLC
    Date Cleared
    2006-02-01

    (54 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGENT MEDICAL AMERICAS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of de-proteinised latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Eclipse, Non-pyrogenic, latex, powder free, sterile surgeon's glove
    Ask a Question
    K Number
    K050899
    Device Name
    BIOGEL LATEX STERILE POWDER-FREE GLOVE
    Manufacturer
    REGENT MEDICAL AMERICAS, LLC
    Date Cleared
    2005-08-12

    (123 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGENT MEDICAL AMERICAS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    A powder-free sterile surgeon's glove is a disposable device made of Natural Rubber Latex that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Ask a Question
    K Number
    K050533
    Device Name
    ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
    Manufacturer
    REGENT MEDICAL AMERICAS, LLC
    Date Cleared
    2005-04-26

    (55 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGENT MEDICAL AMERICAS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.
    Device Description
    A powder-free sterile surgeon's glove is a disposable device made of latex that is worn on the hands, usually in surgical settings, to provide a barrier between the wearer and/or the patient and the surgical environment, and to prevent contamination between the patient and the wearer.
    Ask a Question
    K Number
    K050184
    Device Name
    BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
    Manufacturer
    REGENT MEDICAL AMERICAS, LLC
    Date Cleared
    2005-03-16

    (48 days)

    Product Code
    KGO
    Regulation Number
    878.4460
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGENT MEDICAL AMERICAS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    A powder-free sterile surgeon's glove is a disposable device made of Poly-Isoprene that is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
    Ask a Question

    Page 1 of 1