DUREX PLAY LUBRICANT

K032124 · Ssl Americas, Inc. · HIS · Jan 16, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K032124
• Device Name: DUREX PLAY LUBRICANT
• Applicant: Ssl Americas, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Durex Play™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Device Story

Durex Play™ is a clear, colorless personal lubricant. It is applied topically to the vaginal entry by the user to provide moisture and lubrication. The device is intended for over-the-counter use to facilitate comfort during sexual activity and is compatible with condoms. It functions as a physical lubricant to reduce friction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on composition and intended use similarity to legally marketed predicate devices.

Technological Characteristics

Water-based personal lubricant. Composition: purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide. Water-soluble, clear, colorless liquid.

Indications for Use

Indicated for individuals experiencing vaginal dryness or requiring personal lubrication to facilitate ease and comfort during intimate sexual activity and to enhance condom use.

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

• K-Y Jelly Personal Lubricant (K955648)
• AstroGlide (K935299)

Submission Summary (Full Text)

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JAN 1 6 2004

Image /page/0/Picture/1 description: The image shows the logo for SSL Americas, Inc. The letters "SSL" are in large, bold font, followed by "Americas, Inc." in a smaller, thinner font. A curved line runs above and below the text, creating a swoosh effect.

Office of Requlatory Affairs 3585 Engineering Drive, Suite 200 Norcross, GA 30092-9214 Tel: [phone] Fax: [phone]

KO32124

## Durex Play™, Premarket approval [510(k)] Summary

### Section VIII.1 Submitter Information

SSL Americas 3585 Engineering Dr. Suite 200 Norcross, GA 30092-9214 Phone: 770 - 582 - 2222 Fax: 770 - 582 - 2233 Contact person: Kathleen Harris, Regulatory Affairs Manager, SSL Americas Date of Summary: July 4, 2003

#### Section VIII.2 General Device Information

Device Trade Name: Durex Play™ Device Common Name: Personal lubricant Classification: Patient lubricant

### Section VIII.3 Predicate Devices

K-Y Jelly Personal Lubricant (K955648) AstroGlide (K935299)

### Section VIII.4 Device Description

Durex Play™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.

#### Section VIII.5 Intended Use

Indications: Durex Play™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

### Section VIII.6 Substantial Equivalence

Durex Play™ is substantially equivalent in intended use to K-Y Jelly personal lubricant and AstroGlide and similar in composition. All products are marketed as personal lubricants, safe to use with condoms, water soluble and sold Over-the-Counter.

Image /page/0/Picture/17 description: The image contains two brand logos, "durex" and "SILIPOS". The "durex" logo is enclosed in a rounded rectangle. The "SILIPOS" logo is to the right of the "durex" logo and has a small triangle to the right of the word.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 16 2004

Ms. Kathleen Harris Regulatory Manager SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214

Re: K032124

Trade/Device Name: Durex Play Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: October 16, 2003 Received: October 21, 2003

Dear Ms. Harris:

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.

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) 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

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 the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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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to proceed to the market.

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# Indications for Use

510(k) Number (if known): K032124

Device Name: Durex Play Personal Lubricant

Indications For Use: Durex Play™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Prescription Use (Part 21 CFR 801 Subpart D) ANDYOR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadben

(Division Sign-Off Division of Reproductive, Abdom and Radiological Device

510(k) Number K032124

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