CAUTION CONDOMS

K033163 · Richard Van Haussen America, Inc. · LTZ · Apr 27, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033163
• Device Name: CAUTION CONDOMS
• Applicant: Richard Van Haussen America, Inc.
• Product Code: LTZ · Obstetrics/Gynecology
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5310
• Device Class: Class 2

Indications for 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 Story

Caution Condoms are male latex sheaths designed to cover the penis during sexual intercourse. The device serves as a physical barrier for contraception and prophylaxis against sexually transmitted diseases (STDs), including HIV. The product is available in lubricated versions, both with and without the spermicide Nonoxynol-9. Intended for over-the-counter use by consumers. The device functions mechanically to prevent the exchange of bodily fluids. Proper use is required to achieve the intended prophylactic benefits. Labeling must include an expiration date compliant with 21 CFR 801.435, with shelf life determined by the earlier of the condom or spermicide expiration when applicable.

Clinical Evidence

No clinical data provided; bench testing and compliance with 21 CFR 801.435 regarding expiration dating and shelf-life testing are required.

Technological Characteristics

Latex sheath; lubricated; optional Nonoxynol-9 spermicide. Class II device. Subject to 21 CFR 884.5300 and 884.5310. Must comply with 21 CFR 801.435 for expiration dating.

Indications for Use

Indicated for use by individuals during sexual intercourse for contraception and as an aid in the prevention of STDs, including HIV infection (AIDS).

Regulatory Classification

Identification

A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 7 2004

Mr. Richard Quaison President Richard Van Haussen America, Inc. 5777 W. Century Blvd. #1645 LOS ANGELES CA 90045

Re: K033163

Trade/Device Name: Caution Condoms - Male latex condoms, lubricated, with and without Nonoxynol-9 Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Product Code: 85 HIS Regulation Number: 21 CFR §884.5310 Regulation Name: Condom with spermicidal lubricant Product Code: 85 LTZ Regulatory Class: II Dated: March 1, 2004 Received: March 2, 2004

Dear Mr. Quaison:

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 legally marketed predicate 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, lisung 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 requirements, 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.

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## Page 2 - Mr. Richard Quaison

Please note: this response to your premarket notification submission does not affect any obligation you might have under scctions 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.

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR 884.5300 and 884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in 801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the carlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, 801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in 801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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, International and Consumer Assistance at its toll-free number [phone] or [phone],or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Daniel A. Lyman

for
N
IT

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K033163

Caution Condoms - Male latex condoms lubricated, with and without Device Name: Nonoxynol-9

Indications For 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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Ch. Lyonn

(Division Sign-Off Division of Reproductive, Abdomina and Radiological Devic

510(k) Number K033163

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