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510(k) Data Aggregation
K Number
K212104Device Name
Water-soluble Personal Lubricant
Manufacturer
Date Cleared
2021-11-18
(135 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Foshan PingChuang Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Water-soluble Personal Lubricant is a personal lubricant for penile, anal 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
Water-soluble Personal Lubricant is a non-sterile, water-based personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, EDTA-2Na, and sodium polyacrylate. Water-soluble Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 250 mL polyethylene terephthalate bottles.
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