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510(k) Data Aggregation
K Number
K210857Device Name
Personal Lubricant
Manufacturer
Date Cleared
2021-09-24
(185 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Huanqiu Xuebao Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Personal Lubricant is a water based 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
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, glycerol, hydroxyethyl cellulose, potassium sorbate, methylparaben, carbomer and triethanolamine. Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 300 mL polyethylene terephthalate bottles.
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