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510(k) Data Aggregation
K Number
K041667Device Name
SAN-MAR LABS LUBRICATING JELLY
Manufacturer
SAN-MAR LABORATORIES, INC.
Date Cleared
2005-01-13
(209 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SAN-MAR LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use Lubricating Jelly to lubricate condoms and for personal lubrication when vaginal dryness causes discomfort. It also eases insertion of rectal thermometers, enemas, and tampons.
Device Description
The device is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone. glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.
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K Number
K983216Device Name
CVS PERSONAL LUBRICANT
Manufacturer
SAN-MAR LABORATORIES, INC.
Date Cleared
1999-05-17
(245 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
SAN-MAR LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and the ease of intimate activity.
Device Description
"CVS Personal Lubricant" is a clear , colorless and odorless personal lubricant, which is composed of the following ingredients; Purified Water, Glycerin, Propylene Glycol, Polyquaternium #5, Methyparaben and Propylparaben. The "CVS Personal Lubricant" bottle is composed of high density polyethylene plastic.
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