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510(k) Data Aggregation
K Number
K971028Device Name
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
Manufacturer
Date Cleared
1998-03-02
(347 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
WORLDS-BEST GUMMIVAREFABRIK A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The World's Best Latex Condoms are to completely cover the penis during sexual intercourse for contraception and prophylaxis, and 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, including, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. This product may also combine a latox condom and a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However, the extent of decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom.
Device Description
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