DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM

K042470 · Ssl Americas, Inc. · HIS · Apr 5, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K042470
• Device Name: DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM
• Applicant: Ssl Americas, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Apr 5, 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. The 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; shaped, teat-ended, transparent membrane; lubricated with spearmint-scented silicone fluid. Designed for use by individuals for contraception and prophylactic protection against sexually transmitted diseases. Device conforms to ISO 4074:2002 and ASTM D3492 standards. Provides physical barrier during intercourse.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Natural rubber latex sheath; shaped, teat-ended, transparent; lubricated with 520mg spearmint-scented silicone fluid. Conforms to ISO 4074:2002 and ASTM D3492 standards. 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 Ultra Comfort Latex Rubber Condom (K980319)
• Spearmint scented green condom (K900679)

Submission Summary (Full Text)

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Durex 'Tingling Pleasure' Male Latex Condom Premarket approval [510(k)]

K042470

# Section II Summary

### A. Submitter Information

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.

### C. Date Prepared

July 26, 2004

### D. Proprietary Name

Durex spearmint scented lubricated Male Latex Condom Trade name Durex 'Tingling Pleasure'

#### E. Common Name

Male Latex Condom

# F. Classification Name

માર્ડ

# G. Predicated Device

Durex Ultra Comfort Latex Rubber Condom [510(k) Number K980319]. Spearmint scented green condom [510(k) Number K900679].

# H. Description of the Device

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This device is a shaped, teat ended, transparent condom lubricated with a spearmint scented lubricant, and is designed to conform to national and international voluntary standards, including ISO 4074:2002 and ASTM D3492 except where noted.

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Durex 'Tingling Pleasure' Male Latex Condom Premarket approval [510(k)]

K042470
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#### I. Intended Use of the Device

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

#### J. Technological Characteristics

This condom has the same technological characteristics as the predicate condoms identified. The condoms described in K980319 are shaped. transparent Durex manufactured natural rubber latex condoms with silicone lubricant, and are of the same dimensions, and have the same lubricant dosage as the condom in this application. The only difference between these two condoms is the addition of the spearmint scent in 'Tingling Pleasure'.

The condom described in K900679 is a green pigmented, parallel sided condom which is lubricated with the same spearmint scented silicone fluid lubricant as the 'Tingling Pleasure' condom. The dosage of spearmint scented lubricant on the Tingling Pleasure condom is 520mg. (400mg for the parallel sided condom in K900679).

All three condoms are of the same base latex formulation (with addition of green pigment in the case of K900679).

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Image /page/2/Picture/11 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" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure with three wavy lines extending from the head, resembling hair or a flowing garment.

Public Health Service

APR - 5 2005

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: K042470 Trade/Device Name: Durex® Spearment Scented Lubricated Male Latex Condom (Durex® 'Tingling Pleasure') Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: February 7, 2005 Received: February 10, 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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you'lo organ massage of your device of your device to a legally prematics notification: "The PDF Pinaning sification 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 If you desire specific advice for your de root 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 Also, please note the regulation entired, "Series" information on your responsibilities under the Act from the 807.97). Tour may obtain other general missance 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. Hogdon

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

K042470 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ﺎ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

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(Division Sign-Off)

Division of Reproductive, Abdo and Radiological Devices 510(k) Number

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