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510(k) Data Aggregation
K Number
K091769Device Name
TRUST DAM
Manufacturer
LINE ONE LABORATORIES, INC.
Date Cleared
2010-02-05
(234 days)
Product Code
MSC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
LINE ONE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.
Device Description
This oral dam is made of natural rubber latex, which completely covers a person's pubic areas during oral genital stimulation. This dam has a smooth surface (both sides), nominal lay flat width 154 mm, nominal length 250 mm, and nominal thickness 0.07mm. It is non- lubricated, and food grade cornstarch is used as a dressing material.
The condoms from which the oral dams are made conform to current established national and international voluntary standards which include ASTM D3492:2008; and have been previously cleared by the USFDA (ref: K070830).
The condoms will be offered in the following Colors and Flavors:
1. Yellow Banana
2. Red Strawberry
3. Green Mint
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