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510(k) Data Aggregation

    K Number
    K121925
    Device Name
    POWDERED LATEX SURGEON'S GLOVE
    Manufacturer
    SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
    Date Cleared
    2013-08-28

    (422 days)

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

    SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Powdered Latex Surgeon's Glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
    Device Description
    The glove is made of natural rubber latex. It is powdered with absorbable dusting powder. The sterility status is sterile. It meets all the requirements of ASTM D3577-0951. No colorant is added during manufacture of our Powdered Latex Surgeon's Glove. The color of our glove is ivory.
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    K Number
    K083817
    Device Name
    M. DIOR BRAND
    Manufacturer
    SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.
    Date Cleared
    2009-09-16

    (268 days)

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

    SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    M. Dior Brand Latex Condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections. The device is for over the counter use.
    Device Description
    The condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms are smooth surface straight walled nipple-end (SWNE) style within ASTM standard specifications D-3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54 mm, and minimum thickness of 30 µM.
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