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510(k) Data Aggregation

    K Number
    K092617
    Device Name
    ROYAL GUARD
    Date Cleared
    2010-05-20

    (267 days)

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

    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This is a disposable device intended for medical application that is worn on the examiner's hand to prevent contamination between examiner and patient and to protect examiner from the following Chemotherapy drugs tested to ASTM D 6978 with the indicated Breakthrough Detection Times : Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. Nitrile Powder Free Examination Glove (Blue) * CAUTION: Testing showed average breakthrough time of 40.00minutes with Carmustine. Nitrile Powder Free Examination Glove (Green) * WARNING: DO NOT USE WITH CARMUTINE. Nitrile Powder Free Examination Glove (White) * CAUTION: Testing showed average breakthrough time of 48.00minutes with Thio-Tepa. * WARNING: DO NOT USE WITH CARMUTINE.
    Device Description
    Non Sterile. Powder-Free. Nitrile Examination for Use with Chemotherapy Drugs
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    K Number
    K060229
    Device Name
    POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE
    Date Cleared
    2006-03-15

    (44 days)

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

    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water extractable protein per gram of 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
    Non-Sterile, Powder-Free, Black Latex Examination Gloves, with Protein Labeling Claim (50 micrograms or less of total water soluble protein per gram of glove)
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    K Number
    K052030
    Device Name
    SURGEON'S GLOVE, POWDER FREE
    Date Cleared
    2005-09-13

    (48 days)

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

    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.
    Device Description
    The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber.
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    K Number
    K052031
    Device Name
    POWDERED LATEX SURGEON'S GLOVE
    Date Cleared
    2005-09-12

    (47 days)

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

    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The powdered latex surgeon's glove with protein content labeling claim (200 micrograms or less per gram) is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.
    Device Description
    Powdered Latex Surgeon's Glove with Protein Content Labeling Claim (200 Micrograms or Less per Gram)
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    K Number
    K040406
    Device Name
    POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
    Date Cleared
    2004-05-14

    (87 days)

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

    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A patient examination glove is a disposable device intended for manuations . or er es that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
    Device Description
    POLYMER COATED, CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
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    K Number
    K040408
    Device Name
    POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
    Date Cleared
    2004-03-17

    (29 days)

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

    SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.

    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 hand or finger to prevent contamination between patient and examiner
    Device Description
    POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (less than 50 ug/g per glove)
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