DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT

K020659 · Ssl Americas, Inc. · HIS · Mar 29, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020659
• Device Name: DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
• Applicant: Ssl Americas, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Mar 29, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DUREX Latex Condom with Male Genital Desensitizer Lubricant is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases. The male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation.

Device Story

Natural rubber latex sheath condom; straight-walled, nipple-end design; 180 mm length, 52 mm width. Lubricated with Benzocaine (OTC external analgesic) to temporarily prolong time until ejaculation. Used by consumers for contraception and prophylactic protection against STDs. Device functions as physical barrier; lubricant provides desensitizing effect. Meets ASTM D-3492-97 specifications.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and performance standards (ASTM D-3492-97) consistent with predicate devices.

Technological Characteristics

Natural rubber latex sheath; straight-walled, nipple-end; 180 mm length, 52 mm width. Lubricant contains Benzocaine (OTC drug). Meets ASTM D-3492-97 specifications for rubber contraceptives.

Indications for Use

Indicated for individuals seeking contraception and protection against sexually transmitted diseases; includes male genital desensitizer lubricant to temporarily prolong time until ejaculation.

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.

Predicate Devices

• DUREX Hispano Ico Latex Condom (K952415)
• Male Condom with Desensitizer (K8220088)

Submission Summary (Full Text)

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K020659

## MAR 2 9 2002

510(k) Pre-market Notification DUREX Latex Condom with Male Genital Desensitizer Lubricant SSL-Americas, Inc.

February 28, 2002

### PART VIII. 510(K) SUMMARY

| Submitter by: | SSL Americas, Inc.<br>3585 Engineering Drive<br>Norcross, Georgia 30092 |
|----------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Joyce Ning<br>Vice President, Regulatory Affairs<br>Phone: [phone] |
| Date Prepared: | February 15, 2002 |
| Proprietary Name: | Durex® latex condom with male desensitizer lubricant |
| Common Name: | Latex Condom |
| Classification Name: | Condom (21 CFR § 884.5300) |
| Predicate Device: | DUREX® Hispano Ico Latex Condom (K952415) and<br>Male Condom with Desensitizer (K8220088) |

Description of the Device: DUREX Latex Condom with Male Genital Lubricant is made of a natural rubber latex sheath with lubricant Desensitizer containing Benzocaine, an over-the-counter drug recognized as safe and effective by US FDA under 21 CFR 5300 for condom and 21 CFR Part 348 for external analgesic drug products for over-the-counter human use. The condom is a straightwalled, nipple-end condom with the nominal length of 180 mm and width of 52 mm as required by ASTM D-3492-97.

Intended Use of the Device: DUREX Latex Condom with Male Genital Desensitizer Lubricant has the same intended use as the predicate condom. It is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases (STDs). In addition, the male genital desensitizer lubricant on the condom helps in temporarily prolonging the time till ejaculation.

Technological Characteristics: Both the proposed device and the predicate device are of the similar design meeting ASTM Standard (D3492) specification for Rubber Contraceptives (Male Condoms). Both are straight-walled, nipple-end, lubricated made with the similar formulation of natural rubber latex. The proposed condom is a modification of the predicate device with variation merely in the lubricant application.

Image /page/0/Picture/10 description: The image shows the logo for SSL Americas, Inc. The logo consists of the text "SSL Americas, Inc." with a curved line above and below the text. The text is in a bold, sans-serif font. The logo is in black and white.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Joyce Ning Vice President Regulatory Affairs SSL Americas, Inc. 3585 Engineering Drive, Suite 200 P.O. Box 926090 NORCROSS GA 30092-9214

MAR 2 9 2002

Re: K020659

Trade Name/Device: DUREX® Latex Condom with Male Genital Desensitizer Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: February 28, 2002 Received: March 1, 2002

Dear Ms. Ning:

We have reviewed your Section 510(k) notification of intent to market the device referenced above w durve 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, 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 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.

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.

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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 earlier 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 8801.435(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.

Nancy C Brogdon

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

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K020659

510(k) Pre-market Notification

DUREX Latex Condom with Male Genital Desensitizer Lubricant

SSL-Americas, Inc. February 28, 2002

# PART V. INDICATIONS FOR USE STATEMENT

### 3.0

# Indications for Use Statement

| Applicant: | SSL-Americas, Inc. |
|-----------------------------|----------------------------------------------------------------------------|
| 510(k) Number (if known): * | K020659 |
| Device Name: | DUREX ^® Latex Condom with Male Genital Desensitizer Lubricant |

## Indications for Use:

The DUREX Latex Condom with Male Genital Desensitizer Lubricant is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases. The male genital desensitizer lubricant on the condom helps in temporarily prolonging the time until ejaculation.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | or | Over-The-Counter Use |
|------------------|----|----------------------|
|------------------|----|----------------------|

|--|--|

SSL Americas, Inc.
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K020659 |
|---------------|---------|
|---------------|---------|

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