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510(k) Data Aggregation

    K Number
    K212037
    Device Name
    SancDam Latex Oral Dam
    Manufacturer
    Sanctuary Health Sdn. Bhd.
    Date Cleared
    2022-03-28

    (271 days)

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

    Sanctuary Health Sdn. Bhd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SancDam™ Latex Oral Dam is used as a barrier when engaging in oral/vaginal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
    Device Description
    The SancDam™ Latex Oral Dam are rectangular shaped, non-porous, intact polymer films made of natural rubber latex that are placed over the vagina or anus during oral sexual contact. The dam is used as a physical barrier to cover the external female genitalia or the anal area. The SancDam™ has a smooth surface on both sides. The size of the SancDam™ is 155 mm (± 5 mm) by 254 mm (± 5 mm) by 0.07 mm (± 0.02 mm). The SancDam™ available in 4 different flavors and colors versions as listed below: Pink Strawberry, Green Mint, Yellow Vanilla, Purple Grape.
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