LONG LOVE CONDOM

K033541 · Unidus Corp. · HIS · Dec 23, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K033541
• Device Name: LONG LOVE CONDOM
• Applicant: Unidus Corp.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV. The male genital desensitizer in the condom helps to temporarily prolong the time until ejaculation. If used properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other contraceptive methods.

Device Story

Long Love condom is a natural rubber latex sheath designed to cover the erect penis. Features a straight-walled design with a reservoir tip; nominal length 180-mm, width 52-mm, thickness 0.06-mm. Available lubricated with silicone or non-lubricated; includes cornstarch dressing. Contains Benzocaine as a genital desensitizer to temporarily prolong time until ejaculation. Intended for over-the-counter use by individuals for contraception and prevention of STDs. Device acts as a physical barrier to prevent exchange of bodily fluids during intercourse. Clinical benefit includes pregnancy prevention and reduction of STD transmission risk.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and performance testing in accordance with established national and international voluntary standards (ASTM D3492 and ISO 4074).

Technological Characteristics

Natural rubber latex sheath; straight-walled with reservoir tip; 180-mm length, 52-mm width, 0.06-mm thickness. Lubricated with silicone or non-lubricated; cornstarch dressing. Contains Benzocaine. Conforms to ASTM D3492 and ISO 4074 standards.

Indications for Use

Indicated for use by individuals for contraception and prophylaxis to prevent pregnancy and the transmission of sexually transmitted diseases (STDs), including HIV, chlamydia, genital herpes, gonorrhea, hepatitis B, and syphilis. Includes a genital desensitizer 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

• Lifestyle Male Latex Condom w/ Genital Desensitizer (K030176)

Submission Summary (Full Text)

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## DEC 2 3 2003

K033541

### Abbreviated 510 (k) Notification for a Male Latex Condom

#### II. 510(k) SUMMARY

| Submitted By: | UNIDUS Corporation<br>Seokyung Bldg., 51 Bang-1 Dong<br>Songpa-Ku<br>Seoul, Republic of Korea | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact Persons: | Eli J. Carter<br>Consultant to UNIDUS Corporation<br>1219 Little Creek Road<br>Durham, NC 27713 | B.S. Lee<br>Managing Director<br>UNIDUS Corporation<br>Seokyung Building 51,<br>Bangi-dong, Songpa-Ku<br>Seoul, Korea |
| Date Prepared: | November 5, 2003 | |
| Proprietary Name: | "Long Love" Condom | |
| Common Name: | Male Latex Condom | |
| Classification Name: | Male Latex Condom | |
| Predicate Device: | Lifestyle Male Latex Condom w/ Genital Desensitizer -- K030176 | |
| Description of Device: | This condom is made of a natural latex sheath, which completely<br>covers the erect penis with a closely fitted membrane. This condom is<br>straight-walled with a reservoir tip; nominal length 180-mm, nominal<br>width 52-mm, and nominal thickness 0.06mm. It is either lubricated<br>with silicone or non-lubricated; with cornstarch as a dressing material,<br>and Benzocaine (an over-the-counter drug generally recognized as safe<br>and effective by the USFDA) placed inside the condom for<br>desensitizing the male genitals. This condom is designed to conform to<br>established national and international voluntary standards including<br>ASTM D3492 and ISO 4074. | |
| Intended Use of the Device: | This latex condom has the same intended use as the predicate condom.<br>The condom is used for contraception and for prophylactic purposes to<br>help prevent pregnancy and the transmission of sexually transmitted<br>diseases, including HIV. The male genital desensitizer in the condom<br>helps to temporarily prolong the time until ejaculation. If used | |

il helps to temporarily prolong the time until ejaculation. If used
properly, this condom will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases including chlamydia, genital herpes, gonorrhea, hepatitis B, and syphilis. In addition, this condom will help reduce the risk of pregnancy without the serious side effects sometimes associated with other contraceptive methods.

**Page 5 of 14**

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Technological Characteristics:

This condom has the same technological characteristics as the predicate i condom identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and the condom is made of natural rubber latex. Accordingly, when compared to the predicate device, the UNIDUS condom intended to be introduced does not incorporate any significant changes in the intended use, method of operation, materials, or design that could affect safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem of an eagle-like bird with three stylized lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

UNIDUS Corporation % Mr. Eli J. Carter Consultant 1219 Little Creek Rd. DURHAM NC 27713

Re: K033541

Trade Name/Device: Male Rubber Latex Condom with Genital Desensitizer Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: 85 HIS Dated: November 5, 2003 Received: November 10, 2003

Dear Mr. Carter:

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, listing of devices, good manufacturing practice, labeling, and probibitions 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.

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

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Page 2 - Mr. Carter

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, 8801.435(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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR §807.97). You may obtain other general information on your responsibilities under the Act 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 yours.

David A. Hegmann

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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### Indications for Use

510(k) Number (if known): K033541 Device Name: Male Rubber Latex Condom with Genital Desensitizer Indications for Use: The UNIDUS Condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

**Over-the-Counter Use**
X
(21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lypson

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(Division Sign-Off)

Division of Reproductive, Abdominal. and Radiological Devi 510(k) Number.