TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT

K073016 · Church & Dwight Co., Inc. · HIS · Nov 9, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K073016
• Device Name: TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
• Applicant: Church & Dwight Co., Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Nov 9, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The TROJAN® THINTENSITY™ brand male latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Device Story

Natural rubber latex sheath; covers penis; smooth surface; straight-walled with contoured-bulbous section; reservoir tip. Lubricated with Ultrasmooth™ or Warm Sensations™ lubricant. Used for contraception and prophylactic purposes to prevent pregnancy and sexually transmitted diseases. Over-the-counter use.

Clinical Evidence

No clinical data; substantial equivalence based on design conformance to ASTM D-3492 standards and comparison to predicate device.

Technological Characteristics

Natural rubber latex sheath; straight-walled with contoured-bulbous section and reservoir tip. Conforms to ASTM D-3492 (min length 160 mm, max width 54 mm, min thickness 30 µM). Lubricated with Ultrasmooth™ or Warm Sensations™ lubricants.

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® THINTENSITY™ brand Male Latex Condom with Silicone Lubricant (K071272)

Submission Summary (Full Text)

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K073016

October 23, 2007

Food and Drug Administration Abbreviated 510(k) Notification TROJAN® THINTENSITY™ Brand Male Latex Condoms with Ultrasmooth™ and with Warm Sensations™ Lubricants

III. 510(k) SUMMARY

Page 4 of 88

## Submitter's Name and Address: Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543 Stephen C. Kolakowsky Contact Person: Director, Regulatory Affairs NOV 0 9 2007 Date Prepared: October 2007 TROJAN® THINTENSITY™ brand Proprietary Name: with ULTRASMOOTH™ Lubricant, and with WARM SENSATIONS™ Lubricant Common Name: Male Latex Condom Classification Name: Condom TROJAN® THINTENSITY™ brand Male Latex Condom Predicate Device: with Silicone Lubricant Church & Dwight Co., Inc.; K071272 Description of the Device: The condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is smooth surfaced, straightwalled with a contoured-bulbous section near the closed-end, which terminates with a reservoir tip. The condom design is within the ASTM standard specifications D-3492, e.q., minimum length 160 mm, maximum width 54 mm, and minimum thickness of 30 µM. Each condom is lubricated with either of two varieties of lubricant, ULTRASMOOTH™ lubricant or WARM SENSATIONS™ lubricant. Intended Use of the Device: This latex condom product has the same intended use as the predicate. It is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). Technological Characteristics: The 510(k)-subject condom products have the same technological characteristics as the predicate condom products identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and the condoms are made of natural rubber latex.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 0 9 2007

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

Re: K073016

Trade Name: TROJAN® THINTENSITY™ brand male latex condom lubricated with Ultrasmooth™ lubricant and with Warm Sensations™ lubricant Regulation Number: 21 CFR §884.5300

cler. Et Cl

Regulation Name: condom Regulatory Class: II Product Code: HIS

Dated: October 23, 2007

Received: October 25, 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 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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. 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 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 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

Enclosure

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Page 22 of 88

# VIII. INDICATIONS FOR USE STATEMENT

K073016 510(k) Number:

> TROJAN® THINTENSITY™ brand male latex condom lubricated with Ultrasmooth™ lubricant and with Warm Sensations™ lubricant

Indications For Use:

Device Name:

The TROJAN® THINTENSITY™ brand male latex 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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Preuss

(Division Sign-Off) Division of Reproductive, Abdomina Radiological Devices 510(k) Number