DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT

K042957 · Ssl Americas · HIS · Feb 17, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K042957
• Device Name: DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT
• Applicant: Ssl Americas
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Feb 17, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

This latex condom has the same intended use as the predicate condoms. This lates condom nas the camo mon and for prophylactic purposes (to help The condom is aoou for contrassmission of sexually transmitted diseases). prevent pregnancy and the transmit the same intended use as the predicate rne warming condowhen used as an accessory to a condom. It relieves portonial labrisant and comfort of intimate sexual activity.

Device Story

Durex Warming Pleasure is a natural rubber latex male condom featuring a water-based warming lubricant. Designed to cover the penis as a closely fitted membrane; teat-ended shape. Used by consumers in intimate settings for contraception and disease prevention. The warming lubricant provides a sensation to enhance sexual pleasure. Device conforms to ISO 4074 and ASTM D3492 standards. Physical and release testing confirms product specifications.

Clinical Evidence

Bench testing only. Physical and release testing of the finished product confirmed conformance with required specifications (ISO 4074 and ASTM D3492).

Technological Characteristics

Natural rubber latex sheath; teat-ended shape. Water-based warming lubricant. Conforms to ISO 4074 and ASTM D3492. Non-electronic, mechanical barrier device.

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

• Durex Latex Rubber Condom (K980319)
• Trojan Shared Pleasure condom (K unknown)
• KY Warming liquid personal lubricant (K021492)

Submission Summary (Full Text)

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Premarket Notification [510(k)] application

K 0512957

FEB 1 7 2005

#### Section II Summary

#### Submitter Information A. _

SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 - 582 - 2222 Fax: 770 - 582 - 2233

#### B. Contact Person

Chris Robinson, Controller Head of Global Regulatory Affairs, SSL Americas

## C. Date Prepared

October 8, 2004

#### D. Proprietary Name

Durex Male Latex Condom with warming lubricant. Trade name: Durex Warming Pleasure.

#### E. Common Name

Male Latex Condom

#### F. Classification Name

મારિ

#### G. Predicate Device

Durex Latex Rubber Condom - 510(k) Number K980319 Trojan Shared Pleasure condom - 510(K) Number unknown. KY Warming liquid personal lubricant - 510(k) Number K021492

#### H. Description of the Device

The condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a shaped, teat ended, lubricated condom which is lubricated with a water based warming lubricant.

The device is designed to conform to national and international voluntary standards, including ISO 4074 and ASTM D3492, except where noted.

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### I. Intended Use of the Device

This latex condom has the same intended use as the predicate condoms. This lates condom nas the camo mon and for prophylactic purposes (to help The condom is aoou for contrassmission of sexually transmitted diseases). prevent pregnancy and the transmit the same intended use as the predicate rne warming condowhen used as an accessory to a condom. It relieves portonial labrisant and comfort of intimate sexual activity.

# J. Technological Characteristics

This condom has the same technological characteristics as the predicate rmle Sondom nus the condoms described in K980319 are manufactured of ootuothe latex with the same shape as the condoms in this application. The competitor Trojan Shared Pleasure condoms are Natural Rubber Latex male condoms with 'Warm Sensations' lubricant to help enhance sexual pleasure.

The K-Y Warming liquid (K021492) is a water based, condom compatible personal lubricant which provides a warming sensation. It is of similar composition as the warming lubricant on the Durex condom in this submission.

The condom design conforms to domestic and international regulations: ASTM D3942 and ISO 4074. Physical testing and release testing of the finished product revealed results in conformance with required specifications.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chris Robinson Controller Head of Global Regulatory Affairs SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214

Re: K042957

FEB 1 7 2005

Trade/Device Name: Durex Male Latex Condom with Warming Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: January 31, 2005 Received: February 9, 2005

Dear Mr. Robinson:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FI)A 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and my was finding of substantial equivalence of your device to a legally prematicated notified by one of 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 11 you don't 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/dsma/dsmamain.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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# Durex Male Latex Condom with Warming Lubricant

Premarket Notification [510(k)] application

Indications for Use K042957 510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use: Durex latex condom used for contraception and for manoutic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over-The-Counter Use

01 Subpart D)

(21 CFR 807

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ernst M. Seyrum

Division Sion-Off Division of Reproductive, Abdomina and Radiological Device 510(k) Number

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