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510(k) Data Aggregation
K Number
K152646Device Name
SYLK PERSONAL LUBRICANT
Manufacturer
Date Cleared
2016-03-11
(177 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
TORO MANAGEMENT LLC DBA SYLK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sylk Personal Lubricant is intended for vaginal 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 polyisoprene condoms and polyurethane condoms.
Sylk Personal Lubricant is intended for penile and/or vaginal 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, polyurethane and polyisoprene condoms.
Device Description
Sylk Personal Lubricant is formulated to be a non-sterile, non-greasy, non-sticky, non-staining, viscous liquid. The device is not a contraceptive and does not contain a spermicide. This device is packaged in 3 ounce tubes. The specifications for the Sylk Personal Lubricant include appearance, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total microbial count, total yeast and mold count, and absence of pathogenic organisms.
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