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510(k) Data Aggregation

    K Number
    K023910
    Device Name
    STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES
    Date Cleared
    2003-02-11

    (78 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANREA HEALTHCARE PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An Examination glove is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
    Device Description
    POWDERFREE STERILE LATEX EXAMINATION GLOVES
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    K Number
    K023912
    Device Name
    POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM
    Date Cleared
    2003-02-11

    (78 days)

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

    SANREA HEALTHCARE PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Surgeon's glove is a device made of natural nusber intended to be worn by operating room personnel to protect a surgicul wound from concamination.
    Device Description
    POWDERFREE LATEX SURGEON'S GLOVES . Cantains 50 megm on less of Total Water per gram protect
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    K Number
    K023915
    Device Name
    STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES
    Date Cleared
    2003-02-11

    (78 days)

    Product Code
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    SANREA HEALTHCARE PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An Examination glove is a disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    STERILE PATIENT EXAMINATION GLOVES - POWDERFD
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    K Number
    K023515
    Device Name
    PRE-POWDERED LATEX SURGEON'S GLOVES
    Date Cleared
    2003-01-16

    (87 days)

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

    SANREA HEALTHCARE PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A surgeon's glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination
    Device Description
    pre-POWDERED LATEX SURGEON'S GLOVES
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