(347 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for "World's Best Condoms." It does not contain information about acceptance criteria or a study that proves the device meets those criteria from an AI/device performance perspective.
The letter is the outcome of a regulatory review stating that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for going to market. However, it does not describe specific performance metrics, study designs, sample sizes, or ground truth methodologies that would be typical for an AI/device performance evaluation.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/0 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle, with the words separated by dots.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 2 1998
Re: K971028
World's Best and World's Best Extra Series (non-lubricated, lubricated and spermicidal lubricated latex condoms) Dated: January 12, 1998 Received: January 27, 1998 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HLS 21 CFR 884.5310/Procode: 85LTZ
Mr. Christian Hjorth World's Best Gummivarefabrik A/S 15 Rudolfgaardsvej 8260 Viby J DENMARK
Dear Mr. Hjorth:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and problibitions sgainst misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
W.Lilian Yu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear. Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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なこなしから CCST ひた
510(k) Number (if known): K971028
19792 196 19641
Device Name: Worlds-Best Condoms ..
Indication For 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.
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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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rober D. Satling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971028
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The Counter Use 1/
(Par 21 CFR 801.109)
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§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.