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510(k) Data Aggregation

    K Number
    K233042
    Device Name
    Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
    Manufacturer
    Shandong Intco Medical Products Co, Ltd.
    Date Cleared
    2023-12-06

    (72 days)

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

    Shandong Intco Medical Products Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K231408
    Device Name
    Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
    Manufacturer
    Shandong Intco Medical Products Co, Ltd.
    Date Cleared
    2023-08-11

    (88 days)

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

    Shandong Intco Medical 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 upon the examiner's hands or fingers to prevent contamination between patient and examiner.
    Device Description
    The subject device is a patient examination glove made of synthetic nitrile latex compound. It is Non-Sterile, Powder free and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility per ISO 10993-11.
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    K Number
    K223298
    Device Name
    Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
    Manufacturer
    Shandong Intco Medical Products Co, Ltd.
    Date Cleared
    2023-02-22

    (118 days)

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

    Shandong Intco Medical Products Co, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
    Device Description
    The Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation. The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.
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    K Number
    K213509
    Device Name
    Latex Examination Gloves, Powder Free
    Manufacturer
    Shandong Intco Medical Products Co, Ltd.
    Date Cleared
    2022-04-08

    (157 days)

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

    Shandong Intco Medical 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
    Powder Free Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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