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Found 63 results
510(k) Data Aggregation
K Number
K070937Device Name
MULTIPLE BRAND MALE LATEX CONDOM
Manufacturer
NULATEX SDN. BHD.
Date Cleared
2007-09-21
(170 days)
Product Code
HIS, LTZ
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This [MULTIPLE BRAND] latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Device Description
Not Found
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K Number
K041717Device Name
POWERSTICK MALE LATEX CONDOMS
Manufacturer
A.P.DEAUVILLE, LLC.
Date Cleared
2005-01-13
(203 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Power Stick Male Latex Condom is used for controptive fic fower belen cric purposes (to help prevent pregnancy and for prophylaction of sexually transmitted diseases).
Device Description
This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. These two types of condoms, ribbed and dotted-ribbed, are at a nominal length of 170mm., a nominal width of 52 mm (±2mm) and are at a nominal thickness of .06 mm (±.02 mm).
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K Number
K033163Device Name
CAUTION CONDOMS
Manufacturer
RICHARD VAN HAUSSEN AMERICA, INC.
Date Cleared
2004-04-27
(172 days)
Product Code
LTZ
Regulation Number
884.5310Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases.
Device Description
Caution Condoms - Male latex condoms lubricated, with and without Nonoxynol-9
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K Number
K040185Device Name
DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM
Manufacturer
SSL AMERICAS
Date Cleared
2004-04-27
(91 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This latex condom has the same intended use as the predicate condoms. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Device Description
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, lubricated condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492.
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K Number
K032227Device Name
DUREX FLAVORED LATEX CONDOM
Manufacturer
SSL AMERICAS, INC.
Date Cleared
2004-03-29
(252 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Durex latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Device Description
This condom is made of a natural rubber colored latex sheath, which completely covers the penis with a closely fitted membrane. This device is a parallel sided, teat ended, flavored condom and is designed to conform to national and international voluntary standards, including ISO 4074, EN600 and ASTM D3492. The condom is offered in Chocolate, Chocolate/coconut. Chocolate/peppermint, and Chocolate/orange.
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K Number
K033541Device Name
LONG LOVE CONDOM
Manufacturer
UNIDUS CORP.
Date Cleared
2003-12-23
(43 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNIDUS Condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Device Description
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is either lubricated with silicone or non-lubricated; with cornstarch as a dressing material, and Benzocaine (an over-the-counter drug generally recognized as safe and effective by the USFDA) placed inside the condom for desensitizing the male genitals. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
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K Number
K031007Device Name
KWIKEZE MALE CONDOM APPLICATOR
Manufacturer
CONDAX LLC.
Date Cleared
2003-11-14
(228 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kwikeze Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercourse. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Device Description
The Kwikeze™ Male Condom Applicator is an elliptical ring made of polyethylene plastic. When packaged, the applicator is collapsed on self-scored lines in a manner that allows the condom to be loosely positioned within the inner-folds of the ring. The collapsed applicator is held in position with a polyurethane band. The condom is stretched slightly to position it on top of the applicator. This configuration allows the condom to rest un-stretched until time of use. After opening the sealed foil package, and prior to use, the band is removed allowing the ring and condom to expand to its original oval shape. The device when pulled opened expands the attached condom enough to allow for easy insertion and correct positioning of the condom on the erect penis.
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K Number
K031369Device Name
MERCATOR HEALTHCARE MALE LATEX CONDOM
Manufacturer
MERCATOR HEALTHCARE LTD.
Date Cleared
2003-10-31
(184 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mercator male latex condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)
Device Description
This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180-mm, nominal width 52-mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dressing material. The condom has either a smooth or textured (dotted and/or ribbed) surface. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and ISO 4074.
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K Number
K023333Device Name
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR RIBBED OR 3 IN 1 (DOTTED/RIBBED/CONTOUR
Manufacturer
PLEASURE LATEX PRODUCTS SDN. BHD.
Date Cleared
2003-06-23
(259 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The [No particular brand name] condom is used for contraception and for prophylactic purposes ( to help prevent pregnancy and the transmission of sexually transmitted diseases).
Device Description
[No Particular Brand Name] Colored and/or Flavored Male Natural Rubber Latex Condom, 52mm or 56mm Nominal Width with Smooth or Dotted or Ribbed or 3 in 1 ( Dotted / Ribbed / Contoured) Surface Lubricated with Silicone Oil or Nonoxynol-9 Spermicide.
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K Number
K030176Device Name
LIFESTYLES, CONTEMPO OR PRIVATE LABEL-MALE LATEX CONDOM WITH DESENSITIZING LUBRICANT
Manufacturer
SURETEX, LTD.
Date Cleared
2003-04-17
(90 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
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Matched: '884.5310'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeStyles, Contempo or private label Male Latex Condom with Desensitizing Lubricant is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. Additionally, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation. This condom is intended to be used for contraceptive and prophylactic purposes. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other methods. However, no contraceptive can guarantee 100% effectiveness. Failure to use as directed may further result in loss of protection. Furthermore, sexually transmitted diseases can be transmitted through lesions and various body fluids during intimate contact. Therefore, the condom should be applied before any such contact.
Device Description
These condoms are male contraceptive and prophylactic devices fabricated of natural rubber latex with lubricant containing Benzocaine, an over-the-counter drug generally recognized as safe and effective by the U.S. FDA as a male genital desensitizer (21 CFR Part 348 - External Analgesic Drug Products for Over-the-Counter Human Use). The condoms are designed as fitted sheaths with an integral ring at the open end and a reservoir at the closed end to contain semen. These condoms are designed to conform to established national and international voluntary standards including ASTM D3492, ISO 4074 and EN 600.
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