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510(k) Data Aggregation
K Number
K172306Device Name
SuperSlyde Personal Lubricant
Manufacturer
Date Cleared
2018-04-19
(262 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ICM Pharma Pte Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SuperSlyde lubricant is a personal lubricant, 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 condoms. This product is not compatible with polyurethane and polyisoprene condoms.
Device Description
SuperSlyde is an anhydrous, non-sterile, clear, silicone-soluble liquid for use as a personal lubricant. It is made of dimethicone and dimethiconol. The specifications for SuperSlyde include appearance, color, odor, viscosity, total aerobic microbial count per USP <61>, total yeast and mold count per USP <61> and absence of pathogenic organisms per USP <62>. Osmolality, pH and antimicrobial effectiveness test parameters are not applicable because the subject lubricant is non-aqueous based formulation. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, press-top polypropylene (PP) in volumes of 100ml, 250ml and 400ml.
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