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510(k) Data Aggregation
K Number
K160763Device Name
ally Liquid Personal Lubricant
Manufacturer
Date Cleared
2016-06-29
(100 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
**GUY **& O'NEILL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ally® Liquid 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
ally® Liquid Personal Lubricant is a non-sterile, clear, non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex or polyisoprene condom during intimate sexual activity. This product is not a contraceptive or spermicide. The product is packaged in 2 to 8 ounce plastic bottles with tamper-proof seals.
INGREDIANTS: Purified water, propanediol, hydroxyethylcellulose, hydroxyacetophenone, lactic acid
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K Number
K160717Device Name
ally Warming Liquid Personal Lubricant
Manufacturer
Date Cleared
2016-06-14
(91 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
**GUY **& O'NEILL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ally® Warming Liquid 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Device Description
The device is non-sterile, clear, non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a natural rubber latex or polyisoprene condom during intimate sexual activity. This product is not a contraceptive or spermicide. The product is packaged in 2 to 8 ounce plastic bottles with tamperproof seals.
Ask a Question
Ask a specific question about this device
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