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510(k) Data Aggregation

    K Number
    K052612
    Device Name
    DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2005-11-22

    (61 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00E4.
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    K Number
    K021853
    Device Name
    DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2002-08-01

    (56 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR POWDER FREE WITH VITAMIN E
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    K Number
    K020943
    Device Name
    STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2002-06-06

    (73 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    STERILE DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
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    K Number
    K012339
    Device Name
    ENVIORN-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2001-10-16

    (84 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETTERN PATIENT AND EXPMINER.
    Device Description
    Environ-NF DISPOSABLE SYNTHETIC VINYL EXAM GLOVE, POWDER FREE (YELLOW)
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    K Number
    K012499
    Device Name
    ENVIRON-NP POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2001-10-16

    (74 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXANINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    Environ-NP Powder Free Synthetic Vinyl Examination Gloves
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    K Number
    K003321
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2000-11-22

    (29 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000953
    Device Name
    DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2000-04-20

    (27 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000872
    Device Name
    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    2000-04-05

    (16 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K993049
    Device Name
    DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    1999-11-19

    (70 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE PVC POWDERED SYNTHETIC EXAMINATION GLOVES
    Ask a Question
    K Number
    K992017
    Device Name
    DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
    Manufacturer
    SHANGHAI ANTARES INDUSTRIES, INC.
    Date Cleared
    1999-08-05

    (51 days)

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

    SHANGHAI ANTARES INDUSTRIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
    Device Description
    DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
    Ask a Question

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