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510(k) Data Aggregation
K Number
K163395Device Name
Astroglide Diamond Silicone Gel Personal Lubricant
Manufacturer
BioFilm, Inc.
Date Cleared
2017-02-10
(67 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
BioFilm, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Astroglide® Diamond Silicone Gel 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, polyurethane, and polyisoprene condoms.
Device Description
Astroglide® Diamond Silicone Gel Personal Lubricant is non-sterile, clear, odorless, and silicone-based lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
This product primary packaging is a white LDPE 3 ounce tube with a screw on polypropylene flip-top cap. The tube and cap constitute the device final packaging.
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K Number
K141132Device Name
ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
Manufacturer
BIOFILM, INC.
Date Cleared
2015-01-09
(253 days)
Product Code
PEB
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
BIOFILM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Astroglide® TTC 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. Astroglide TTC is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. Astroglide® TTC is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
Device Description
Astroglide® TTC Fertility Friendly Personal Lubricant is a non-sterile, clear, and water-based personal lubricant for penile and/or vaginal application. Astroglide® TTC has a pH and osmolarity that is compatible with sperm survival and migration. The device is packaged in pre-filled tube applicators which may be used for single use intra-vaginal application or applied directly to penis or vagina. Astroglide® TTC is formulated using water, propylene glycol, hydroxyethylcellulose, fructose, methylparaben, sodium phosphate, potassium phosphate, propyl paraben, galactose, and sodium hydroxide. This device is batch lot tested for appearance, color, viscosity, pH, microbial count, osmolality, endotoxin, mouse embryo assay and human sperm survival assay.
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K Number
K140590Device Name
ASTROGLIDE SENSUAL STRAWBERRY
Manufacturer
BIOFILM, INC.
Date Cleared
2014-10-30
(237 days)
Product Code
NUC, CLA
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
BIOFILM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Astroglide Sensual Strawberry 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, polyisoprene, and polyurethane condoms.
Device Description
Astroglide Sensual Strawberry personal lubricant is non-sterile, clear. colorless, and water based. It has a subtle flavor and fragrance of strawberry. Astroglide Sensual Strawberry is a proprietary blend consisting mainly of water soluble ingredients similar to the predicate device and other personal lubricant devices currently on the market. This product is not a spermicide or contraceptive. The product is provided in a clear bottle or a tube with flip top cap and it is compatible with natural rubber latex, polyisoprene and polyurethane condoms.
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K Number
K141581Device Name
ASTROGLIDE NATURAL
Manufacturer
BIOFILM, INC.
Date Cleared
2014-08-06
(54 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
BIOFILM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Astroglide® Natural 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 ONLY compatible with natural rubber latex and polyisoprene condoms.
Device Description
Astroglide Natural personal lubricant is non-sterile, clear and water based. Astroglide® Natural is a proprietary blend consisting mainly of water soluble ingredients similar to other lubricants currently on the market. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product primary packaging is a clear PET bottle with a screw on flip top cap comprised of polypropylene. Each bottle is packaged into a cardboard carton, which constitutes the device outer packaging.
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K Number
K072647Device Name
GLYCERIN & PARABEN FREE ASTROGLIDE
Manufacturer
BIOFILM, INC.
Date Cleared
2008-01-25
(128 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
BIOFILM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, 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 latex condoms.
Device Description
Glycerin & Paraben Free Astroglide® is a non-sterile, clear, non-greasy, high viscosity liquid used as a personal lubricant. Glycerin & Paraben Free Astroglide® is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
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K Number
K041432Device Name
ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
Manufacturer
BIOFILM, INC.
Date Cleared
2004-11-30
(186 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
BIOFILM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Recommended as a personal lubrication to enhance intimate activities.
Device Description
Astroglide® Brand WARMING LIQUID is a non-sterile clear non-greasy, high viscosity liquid used as a personal lubricant. The product is highly lubricous and may be used with or without a condom during sexual activity. Astroglide® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in condom compatibility testing conducted according to standards defined by ASTM D 3492.
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K Number
K020586Device Name
GOOD LUBRICATIONS
Manufacturer
BIOFILM, INC.
Date Cleared
2003-01-24
(336 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Applicant Name (Manufacturer) :
BIOFILM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Good Lubrications patient lubricant is a medical device intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Good Lubrications is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse.
Good lubrications may be used with condoms.
Device Description
Good Lubrications Personal Lubricant
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K Number
K003867Device Name
EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET)
Manufacturer
BIOFILM, INC.
Date Cleared
2001-03-09
(87 days)
Product Code
NUC
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
BIOFILM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A lubricant for non-sterile gynecological and hospital procedures. Not harmful to rubber appliances or medical instruments.
Recommended for personal lubrication when vaginal dryness causes discomfort. Lubrication for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.
Device Description
Not Found
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