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510(k) Data Aggregation

    K Number
    K081413
    Device Name
    TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
    Manufacturer
    DAILIAN LATEX COMPANY, LTD.
    Date Cleared
    2008-10-24

    (157 days)

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

    DAILIAN LATEX COMPANY, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Twinlotus or Shield condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
    Device Description
    This condom is made of high quality natural rubber latex, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip ; nominal length 160mm, nominal width 52 +/- 2mm, and nominal thickness 0.07 +/- 0.01mm. It is lubricated with methyl silicone and white carbon black is used as a dressing material. The condom is colored and flavored, and designed to conform to the latest national and international voluntary standards including ISO 4074 、 ISO 10993 and ASTM D3492. The condoms will be offered in a variety of colors and flavors. The condoms also are offered in ribbed and studded configurations.
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