Search Filters

Search Results

Found 31 results

510(k) Data Aggregation

    K Number
    K112693
    Device Name
    NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2012-09-12

    (363 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-Sterile, Powder-Free Yellow Latex Examination Glove With Tutti Flavour and With Protein Labeling Claim of <50 ug/dm² per 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 Yellow Latex Examination Gloves With Tutti Frutti Flavour and with Protein Labeling Claim of <50 ug/dm² Per Glove
    Ask a Question
    K Number
    K101822
    Device Name
    NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2010-11-19

    (142 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A disposable medical glove to be worn on the hand of the healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
    Device Description
    Non-sterile , Powder-free Blue Nitrile Examination Gloves , Tested for use with Chemotherapy Drugs.
    Ask a Question
    K Number
    K101646
    Device Name
    NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2010-09-08

    (89 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-sterile Powder Free Black Nitrile Examination Gloves with Cherry Flavor, 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
    Doves I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00a (2005) Standard Specification for Nitrile Examination Gloves for Medical Application.
    Ask a Question
    K Number
    K072400
    Device Name
    NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2008-03-27

    (213 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-sterile Powder Free Black Nitrile Examination Gloves , 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
    Class I Nitrile examination gloves 80LZA, powder free and meeting all the requirements of ASTM D6319-00aE3 Standard Specification for Nitrile Examination Gloves for Medical Application.
    Ask a Question
    K Number
    K072403
    Device Name
    NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2008-03-27

    (213 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-Sterile Powdered Pink Latex Examination Gloves with Cherry Flavour and with Protein Labeling claims (200 Micrograms or less) 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
    Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.
    Ask a Question
    K Number
    K072406
    Device Name
    NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2008-03-21

    (207 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-Sterile, Powder Free Pink Latex Examination Gloves with Cherry Flavour and with protein labeling claims (50 Micrograms or less) 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
    Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-05 Standard Specification for Latex Examination Gloves for Medical Application.
    Ask a Question
    K Number
    K071060
    Device Name
    NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2007-07-26

    (101 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate, with Protein Labeling claims (50 Micrograms or less) 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
    Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Gloves for Medical Application.
    Ask a Question
    K Number
    K052016
    Device Name
    NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2005-09-01

    (37 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Non-Sterile, Latex, Powder-Free Patient Examination Gloves (Multicolored), with Protein Labeling Claim (50 Micrograms or less) 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
    Class I latex patient examination gloves 80LYY, powder free and mecting all the requirements of ASTM-D3578-01aE2 Standard Specification for Latex Examination Glowes for Medical Application.
    Ask a Question
    K Number
    K042879
    Device Name
    NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2005-01-13

    (87 days)

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

    SGMP CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Class I nitrile patient examination gloves 80LZA, powder free and meeting all the requirements of ASTM-D6319-00aE1 Standard Specification for Nitrile Examination Gloves for Medical Application.
    Ask a Question
    K Number
    K023537
    Device Name
    NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
    Manufacturer
    SGMP CO., LTD.
    Date Cleared
    2003-11-20

    (395 days)

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

    SGMP CO., LTD.

    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
    Class I latex patient examination gloves 80LYY, powder free and meeting all the requirements of ASTM-D3578-01ar2 Standard Specification for Latex Examination Gloves for Medical' Application.
    Ask a Question

    Page 1 of 4