DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT

K072236 · Ssl Americas · NUC · May 7, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K072236
• Device Name: DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
• Applicant: Ssl Americas
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: May 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Durex Play ™Tingling aqueous based lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturise and Jubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms.

Device Story

Durex Play™ Tingling is a water-soluble, aqueous-based personal lubricant. Applied topically to penile and/or vaginal areas by the user to provide lubrication and moisture during intimate sexual activity. Enhances ease and comfort of sexual intercourse. Compatible with natural rubber latex condoms. Over-the-counter use.

Technological Characteristics

Aqueous-based, water-soluble personal lubricant. Formulated as a slightly hazy/clear liquid. Compatible with natural rubber latex condoms.

Indications for Use

Indicated for individuals requiring personal lubrication for penile and/or vaginal application to enhance comfort during intimate sexual activity and supplement natural lubrication. Compatible with natural rubber 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 Play™ Personal Lubricant (K032124)

Submission Summary (Full Text)

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K672236

Durex Play™ Tingling Aqueous Based Lubricant Premarket Approval 510(K) Application.

MAY - 7 2008

## Section VIII: Durex Play™ Tingling Lubricant Premarket approval [510(k)] Application Summary.

## Section VIII.1 Submitter Information

SSL Americas 3585 Engineering Drive Suite 200 Norcross GA 30092-9214. Phone:[phone] Fax:[phone] Contact Person: Chris Robinson, Head of Regulatory Compliance. Alternative contact person: Janice Jose, Associate Regulatory Controller Date of summary: July 2007.

# Section VIII.2 General Device Information

Device trade Name: Durex Play™ Tingling aqueous based lubricant. Device common name: Personal Lubricant Classification: Patient Lubricant

### Section VIII.3 Predicate devices.

Durex Play™ Personal Lubricant (K032124)

#### Section VIII.4 Device Description

Durex Play™ Tingling aqueous based personal lubricant is a slightly hazy/clear, water soluble personal lubricant.

#### Section VIII.5 Intended Use

Indications: The Durex Play ™Tingling aqueous based lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturise and Jubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms.

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Image /page/1/Picture/11 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### MAY - 7 2008

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

Re: K072236

Trade/Devices Name: Durex Play Tingling Aqueous Based Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Dated: April 18, 2008 Received: April 24, 2008

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 (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 (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.

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 max 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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Durex Play™ Tingling Aqueous Based Lubricant Premarket Approval 510(K) Application.

#### Section IV.3 Indications for Use

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Durex Play™ Tingling aqueous based Lubricant

The Durex Play™ Tingling aqueous based Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturise and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is only compatible with natural rubber latex condoms.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ion of Renroductive. Andominal and Radiological Dey 510(k) Number

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