TROJAN-ENZ BRAND

K071313 · Church & Dwight Co., Inc. · HIS · Oct 26, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K071313
• Device Name: TROJAN-ENZ BRAND
• Applicant: Church & Dwight Co., Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Oct 26, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This latex condom product has the same intended use as the predicates. It is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases.)

Device Story

TROJAN-ENZ® brand male latex condom; natural rubber latex sheath; straight-walled nipple-end (SWNE) design. Device covers penis as physical barrier. Used for contraception and prophylactic protection against STDs. Over-the-counter use. Manufactured by contract manufacturer using specific compounded latex formulation.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and conformance to ASTM D3492 standards.

Technological Characteristics

Natural rubber latex; straight-walled nipple-end (SWNE) style. Conforms to ASTM D3492 (min length 160 mm, max width 54 mm, min thickness 30 μM).

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted diseases in individuals using male latex condoms.

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

• TROJAN-ENZ® Male Latex Condoms (Pre-1976 Device)
• Multiple Brands, Sagami Rubber Industries Co., Ltd (K897129)

Submission Summary (Full Text)

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# 长071313

Food and Drug Administration Abbreviated 510(k) Notification
TROJAN-ENZ® Brand Male Latex Condoms 007 26 2007

May 8, 2007

Page 4 of 92

# III. 510(k) SUMMARY

| Submitter's Name and Address: | Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen C. Kolakowsky<br>Director, Regulatory Affairs |
| Date Prepared: | May 2007 |
| Proprietary Name: | TROJAN-ENZ® brand |
| Common Name: | Male Latex Condom |
| Classification Name: | Condom |
| Predicate Device: | TROJAN-ENZ® Male Latex Condoms<br>Church & Dwight Co., Inc.<br>Pre-1976 Device<br>and<br>Multiple Brands<br>Sagami Rubber Industries Co., Ltd<br>K897129 |
| Description of the Device: | The condoms are made of a natural rubber latex sheath,<br>which completely covers the penis with a closely fitted<br>membrane. The condoms are smooth surface straight-<br>walled nipple-end (SWNE) style within ASTM standard<br>specifications D-3492 Table 1 requirements, e.g.,<br>minimum length 160 mm, maximum width 54 mm, and<br>minimum thickness of 30 μM. |
| Intended Use of the Device: | This latex condom product has the same intended<br>use as the predicates. It is used for contraception<br>and for prophylactic purposes (to help prevent<br>pregnancy and the transmission of sexually<br>transmitted diseases.) |
| Technological Characteristics: | The proposed modified condom product would have<br>the same technological characteristics as the predicate<br>condom product identified above. The design is in<br>conformance with ASTM Latex Condom Standard<br>D3492 and the condoms are made of natural rubber<br>latex. The proposed modified condom product are<br>equivalent to the current TROJAN-ENZ® brand male<br>latex condoms in all respects except they would be<br>manufactured by a contract manufacturer utilizing the<br>contract manufacturer's compounded latex<br>formulation. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized symbol that resembles an abstract human figure with three flowing lines above it.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 26 2007

Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Church and Dwight Co. Inc. 469 North Harrison Street Law Department, Building 100 PRINCETON NJ 08543

Re: K071313

> Trade Name: TROJAN-ENZ® Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: October 16, 2007 Received: October 17, 2007

Dear Mr. Kolakowsky:

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 (PMA), 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.

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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 not mean 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 liating (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 edectionic 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 10(a)/ marketed predicate device results in a classification for your device and thus, permorts 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance produce 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CCDH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Smy all 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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May 8, 2007

Page 18 of 92

## VIII. INDICATIONS FOR USE STATEMENT

510(k) Number: Device Name: Indications For Use:

K071313 TROJAN-ENZ® brand Male Latex Condom The TROJAN-ENZ® brand condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Prescription Use _ (Per 21 CFR §801.109) Over-The-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Harlan Leven

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _