WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED

K971028 · Worlds-Best Gummivarefabrik A/S · HIS · Mar 2, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K971028
• Device Name: WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
• Applicant: Worlds-Best Gummivarefabrik A/S
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

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 latex 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 Story

Latex condom device; intended for use during sexual intercourse; provides physical barrier for contraception and reduction of STD transmission risk. Variants include non-lubricated, lubricated, and spermicidal lubricated (nonoxynol-9) versions. Over-the-counter use; intended for general population. Functions as mechanical barrier; spermicidal variant provides chemical adjunct to reduce sperm activity in event of leakage. No electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on established material properties and intended use of latex condoms.

Technological Characteristics

Latex rubber construction; available in non-lubricated, lubricated, and spermicidal (nonoxynol-9) configurations. Mechanical barrier device; no energy source or software.

Indications for Use

Indicated for use by individuals during sexual intercourse for contraception and prophylaxis against STDs, including HIV, chlamydia, herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAR - 2 1998

Mr. Christian Hjorth
World's Best Gummivarefabrik A/S
15 Rudolfgaardsvej
8260 Viby J
DENMARK

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

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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


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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510(k) Number (if known): K971028

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.

This product may also combine a latex 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)

(Rolev D. Sathin)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971028

Prescription Use ☐ OR Over-The Counter Use ☑

(Per 21 CFR 801.109)