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510(k) Data Aggregation
K Number
K223519Device Name
Carex Hybrid Personal Lubricant
Manufacturer
Date Cleared
2023-08-11
(261 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
Karex Industries Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Carex Hybrid Personal Lubricant 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
Not Found
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K Number
K150743Device Name
Water Based Personal Lubricant with Flavours
Manufacturer
Date Cleared
2015-11-12
(234 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
KAREX INDUSTRIES SDN. BHD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Karex's water based personal lubricant with flavors 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 condoms. This product is not compatible with polyisoprene and polyurethane condoms.
Device Description
Water Based Personal Lubricant with Flavors
- Vanilla
- Aloe Vera
- Strawberry
- Banana
- Peppermint
- Chocolate
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