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510(k) Data Aggregation
K Number
K033076Device Name
LIFESTYLES LIQUID PERSONAL LUBRICANT
Manufacturer
ANSELL HEALTHCARE, INC.
Date Cleared
2003-12-19
(81 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LifeStyles® Liquid Personal Lubricant is principally intended as personal lubricant to supplement the body's natural lubrication fluids, to moisturize, and to enhance the comfort and ease of intimate sexual activity with or without a latex condom.
Device Description
LifeStyles® Liquid Personal Lubricant is a non-sterile, water-based personal lubricant designed to supplement the body's natural lubrication fluids. The formula is a non-greasy, non-sticky, non-staining and non-irritating gel-like liquid that is compatible with latex condoms in laboratory testing. LifeStyles® Liquid Personal Lubricant is available over-the-counter in three formulas: LifeStyles® Liquid Personal Lubricant Long Lasting LifeStyles® Liquid Personal Lubricant Aloe & Vitamin E LifeStyles® Liquid Personal Lubricant Strawberry. The product is packaged in a plastic tube with a flip-top cap or in an aluminum foil/plastic film laminate sachet.
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K Number
K001883Device Name
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
Manufacturer
ANSELL HEALTHCARE, INC.
Date Cleared
2000-07-31
(40 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ANSELL HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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