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510(k) Data Aggregation

    K Number
    K240790
    Device Name
    Polyisoprene Surgical gloves
    Manufacturer
    Suzhou Colour-way New Material Co., Ltd.
    Date Cleared
    2024-08-23

    (154 days)

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

    Suzhou Colour-way New Material Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polyisoprene Surgical Gloves are single use device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. It is provided sterile.
    Device Description
    Polyisoprene Surgical gloves
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    K Number
    K222620
    Device Name
    Sterilized Latex Surgical Gloves
    Manufacturer
    Suzhou Colour-way New Material Co., Ltd.
    Date Cleared
    2023-03-23

    (205 days)

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

    Suzhou Colour-way New Material Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterilized Latex Surgical Glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The proposed sterilized latex surgical gloves are powder-free, sterile, single use, surgical gloves intended to be worn by operating room personnel to protect a surgical wound from contamination. The gloves are natural color (no colorant added). The gloves are offered in sizes of 6.5, 7, 7.5, 8, 8.5, 9. The gloves are designed and manufactured in accordance with the ASTM D3577-19 standard.
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    K Number
    K222611
    Device Name
    Male Latex Condoms
    Manufacturer
    Suzhou Colour-way New Material Co., Ltd.
    Date Cleared
    2022-11-28

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Colour-way New Material Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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