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510(k) Data Aggregation

    K Number
    K051913
    Device Name
    POWDERED LATEX PATIENT EXAMINATION GLOVES
    Date Cleared
    2005-09-30

    (77 days)

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

    SHINEMOUND ENTERPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
    Device Description
    Powdered Latex Patient Examination Gloves
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    K Number
    K994248
    Device Name
    SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
    Date Cleared
    2000-01-28

    (43 days)

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

    SHINEMOUND ENTERPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination gloves 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
    Prepowdered Synthetic Vinyl Patient Examination Gloves, Beige color(Sensi-Pro)
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    K Number
    K994258
    Device Name
    SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
    Date Cleared
    2000-01-20

    (34 days)

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

    SHINEMOUND ENTERPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination gloves 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
    Powder Free Synthetic Vinyl Patient Examination Gloves, Beige color(Sensi-Pro)
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    K Number
    K993231
    Device Name
    SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
    Date Cleared
    1999-10-27

    (30 days)

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

    SHINEMOUND ENTERPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination gloves 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
    Sensi-Pro Disposable Powdered Vinyl Synthetic Examination Gloves
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    K Number
    K993240
    Device Name
    SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
    Date Cleared
    1999-10-27

    (30 days)

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

    SHINEMOUND ENTERPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination gloves is a disposabledevice intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    Powder Free Vinyl Synthetic Examination Gloves, White color(Sensi-Pro)
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    K Number
    K971360
    Device Name
    SYNTEX
    Date Cleared
    1997-12-22

    (255 days)

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

    SHINEMOUND ENTERPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
    Device Description
    Powder Free Vinyl Examination Gloves
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    K Number
    K972104
    Device Name
    LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES
    Date Cleared
    1997-08-15

    (72 days)

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

    SHINEMOUND ENTERPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
    Device Description
    Powdered Vinyl Synthetic Examination Gloves
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    K Number
    K970625
    Device Name
    POLY-MED
    Date Cleared
    1997-03-27

    (36 days)

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

    SHINEMOUND ENTERPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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