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510(k) Data Aggregation

    K Number
    K992337
    Device Name
    BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
    Manufacturer
    MEXPO INTL., INC.
    Date Cleared
    1999-08-17

    (35 days)

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

    MEXPO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990210
    Device Name
    POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP
    Manufacturer
    MEXPO INTL., INC.
    Date Cleared
    1999-03-29

    (67 days)

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

    MEXPO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    With Protein Content Labeling Claim (100 micrograms or less of total water extractable Protein per gram). A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    BLOSSOM™ Powdered Latex Examination Gloves
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    K Number
    K984040
    Device Name
    BLOSSOM POWDERED LATEX EXAMINATION GLOVES
    Manufacturer
    MEXPO INTL., INC.
    Date Cleared
    1999-01-13

    (62 days)

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

    MEXPO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove is worn on the hand of health care and similar personnel and the patient, A medical glove is worn on one nation between health
    Device Description
    BLOSSOM TM Powdered Latex Examination Gloves
    Ask a Question
    K Number
    K974782
    Device Name
    LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
    Manufacturer
    MEXPO INTL., INC.
    Date Cleared
    1998-02-24

    (64 days)

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

    MEXPO INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    SUPERGLOVES Powder Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or less)
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