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510(k) Data Aggregation
K Number
K162569Device Name
YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
Manufacturer
Date Cleared
2017-06-09
(267 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
BIOTECH LUBRICANTS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® oil-based Personal Lubricant is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® water-based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. YES® Vaginal Moisturizer is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
YES® oil-based Personal Lubricant: This non-sterile and oil-based personal lubricant consists primarily of Sunflower oil and Shea butter, and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is a cream-colored thick paste that melts at body temperature. The product is packaged in a high density polyethylene (HDPE) tube with a flip-top cap.
YES® water-based Personal Lubricant: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.
YES® Vaginal Moisturizer: This non-sterile and water-based personal lubricant contains Aloe vera and other components, and is compatible with natural rubber latex, and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is neither a contraceptive nor a spermicide. The formulation is a lightly opaque, non-greasy liquid gel. The product is packaged in a HDPE tube with a flip-top cap, and a HDPE single-use applicator.
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