GREEN LOVE MALE CONTRACEPTIVE (CONDOM)

K051842 · Cupid Condom, Ltd. · HIS · Apr 14, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K051842
• Device Name: GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
• Applicant: Cupid Condom, Ltd.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Apr 14, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• 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

Green Love is a natural rubber latex male condom with a reservoir tip and silicone lubricant. Designed as a closely fitted sheath to cover the penis during sexual intercourse. Used by consumers in an over-the-counter setting for contraception and disease prevention. Functions as a physical barrier to reduce the risk of pregnancy and transmission of sexually transmitted infections. No electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and conformance to ASTM D 3492-03 standards.

Technological Characteristics

Natural rubber latex sheath; silicone lubricated; reservoir tipped; conforms to ASTM Latex Condom Standard D 3492-03.

Indications for Use

Indicated for use by individuals during sexual intercourse for contraception and as a prophylactic aid to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV (AIDS).

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

• KAMA SUTRA Latex Lubricated Condom (K931077/B)

Submission Summary (Full Text)

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K051842

## 510 = K SUMMARY

APR 1 4 2006

| Submitted by | CUPID CONDOM LIMITED<br>A-68, M.I.D.C. (Malegaon)<br>Sinnar, Nasik - 422133<br>Maharashtra, INDIA |
|----------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Mr. K.K. GOYAL / Mr. O.P. GARG |
| Date Prepared | 30th June 2005 |
| Proprietary Name | GREEN LOVE |
| Common Name | Natural Latex, silicone lubricated, reservoir<br>tipped, Condom |
| Classification Name | Condom (21 CFR 884.5300) |
| Predicate Device<br>510 - K No : | KAMA SUTRA Latex Lubricated Condom<br>K 931077 / B |

Description of Device: This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted This condom has the specification as enclosed in membrane. Annexure 2

Intended use of the Device: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purpose (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Technological Characteristics: This condom has the same technological characteristics as the predicate condom identified above. This condom design is in conformance with ASTM Latex Condom Standard D 3492-03 and that the condom is made of natural rubber latex

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 1 4 2006

Mr. K.K. Goyal C.E.O. Cupid Condom Ltd. A-68 M.I.D.C. Sinnar MALEGAON, Nashik, 422 113 INDIA

Re: K051842

Trade/Device Name: Green Love Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: March 10, 2006 Received: March 14, 2006

Dear Mr. Goyal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/1/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a circular border with additional text, but the text is too small to read.

Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

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): K051842

Device Name: Green Love Male Latex Condom

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 X (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Ingram
(Division S:

Division and Rac

510(k) Numuz

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