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510(k) Data Aggregation

    K Number
    K102096
    Device Name
    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2010-10-04

    (69 days)

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

    SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs and their breakthrough detection times are as follows: Chemotherapy Drug | Average BDT --------------------|------------- Fluorouracil | >240 min. Etoposide (Toposar) | >240 min. Cyclophosphamide (Cytoxan) | >240 min. Carmustine | 2.03 min. Thiotepa | 25.23 min. Paclitaxel (Taxol) | >240 min. Doxorubicin Hydrochloride | >240 min. Dacarbazine (DTIC) | >240 min. Cisplatin | >240 min. Please note that Carmustine and Thiotepa have extremely low permeation times of less than 30 minutes.
    Device Description
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Polymer Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D 6319-00a (2005)e1.
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    K Number
    K052877
    Device Name
    POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2005-11-08

    (27 days)

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

    SYNTEX HEALTHCARE PRODUCTS 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 hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. A patient examination glove is 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
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Patient Examination Glove, 80 LZA, and meets all requirements of ASTM standard D-6319-00€3
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    K Number
    K042226
    Device Name
    SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2004-09-30

    (44 days)

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

    SYNTEX HEALTHCARE PRODUCTS 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
    Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
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    K Number
    K033777
    Device Name
    ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2004-02-05

    (63 days)

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

    SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between health care personnel and the patient.
    Device Description
    Ultrasense AF Blue Power-free Nitrile Examination Gloves
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    K Number
    K023826
    Device Name
    SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE-BLUE COLOR
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2003-01-24

    (67 days)

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

    SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
    Device Description
    Syntex Powder-Free Latex Examination Gloves - Blue Color. A powder-free patient examination glove is a disposable device made of natural rubber latex that may bear a trace amount of glove powder.
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    K Number
    K022784
    Device Name
    SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2002-11-13

    (83 days)

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

    SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    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
    Powder-Free Nitrile Examination Glove -- Purple Color
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    K Number
    K022088
    Device Name
    SYNTEX POWDER-FREE LATEX EXAMINATION GLOVE
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2002-09-03

    (68 days)

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

    SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
    Device Description
    Syntex Powder-Free Latex Examination Glove
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    K Number
    K022090
    Device Name
    SYNTEX PRE-POWDERED NITRILE EXAMINATION GLOVE
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2002-09-03

    (68 days)

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

    SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
    Device Description
    Pre-Powdered Nitirile Examination Glove
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    K Number
    K022092
    Device Name
    SYNTEX PRE-POWDERED LATEX EXAMINATION GLOVE
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2002-09-03

    (68 days)

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

    SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    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
    Syntex Pre-Powdered Latex Examination Glove
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    K Number
    K022146
    Device Name
    SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE
    Manufacturer
    SYNTEX HEALTHCARE PRODUCTS CO. LTD.
    Date Cleared
    2002-09-03

    (63 days)

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

    SYNTEX HEALTHCARE PRODUCTS CO. LTD.

    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
    Powder-Free Polymer-Coated Latex Examination Glove
    Ask a Question

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