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510(k) Data Aggregation
K Number
K171516Device Name
Flip Lube
Manufacturer
Date Cleared
2018-02-05
(257 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Imquest Biosciences Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
FLIP Lube is personal lubricant for penile, vaginal, and/or rectal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and synthetic polyisoprene condoms. Not compatible with polyurethane condoms.
Device Description
FLIP Lube is a water-based, personal lubricant used to provide lubrication during sexual intercourse. It is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. The specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.
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