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510(k) Data Aggregation
K Number
K984392Device Name
ANSELL CONDOMS
Manufacturer
ANSELL, INC.
Date Cleared
1999-07-21
(225 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ANSELL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ansell condoms are male contraceptive devices, fabricated of latex, which are designed to completely cover the penis during sexual intercourse. These condoms are intended to be used for contraceptive and prophylactic purposes. If used properly, these condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital warts, gonorrhea, hepatitis B, and syphilis. In addition, these condoms 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 condoms should be applied before any such contact.
Device Description
Ansell condoms are male contraceptive and prophylactic devices, which are fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. Ansell condoms are designed to conform to established national and international voluntary standards including ASTM D 3492, ISO 4074 and EN 600.
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K Number
K983518Device Name
LIFESTYLES XTRA PLEASURE
Manufacturer
ANSELL, INC.
Date Cleared
1999-07-06
(272 days)
Product Code
HIS
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
ANSELL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LifeStyles Xtra Pleasure condom is a male contraceptive device, fabricated of latex, which is designed to completely cover the penis during sexual intercourse. 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
The LifeStyles Xtra Pleasure condom is a male contraceptive and prophylactic device, which is fabricated of a natural rubber latex. The condom is designed as a fitted sheath with an integral ring at the open end and a reservoir at the closed end to contain semen. While the shaft of the condom is straight, the closed end is flared and terminates to a nipple at the tip. The "flare" is intended to enhance stimulation by the condom.
The acceptable lengths of this condom are established at between 170-180mm. as permissible by ASTM standard D3492-96. Likewise, acceptable widths of the shaft range from 51-54mm, and thicknesses range from 0.060-0.075mm. The maximum bulb (or flared) width is not to exceed 81mm, per internal specifications.
The LifeStyles Xtra Pleasure Condom shall be packaged with the same polysiloxane fluid lubricant, as is applied to the predicate device.
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