DIVAS DUAL PLEASURE MALE LATEX CONDOM

K051273 · Eagle Twe, Inc. · HIS · Aug 19, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051273
• Device Name: DIVAS DUAL PLEASURE MALE LATEX CONDOM
• Applicant: Eagle Twe, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Aug 19, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The Divas Dual Pleasure condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. The warming condom lubricant has the same intended use as the predicate personal lubricants when used as an accessory to a condom. It relieves friction and facilitates ease and comfort of intimate sexual activity.

Device Story

Divas Dual Pleasure Male Latex Condom is a teat-ended, natural rubber latex sheath; lubricated with water-based warming lubricant. Designed for over-the-counter use to prevent pregnancy and sexually transmitted diseases. Lubricant reduces friction during intimate sexual activity. Device conforms to established voluntary standards for condom safety and performance.

Clinical Evidence

Bench testing only. Device conforms to ISO 4074 and ASTM D3492 standards for condom performance and safety.

Technological Characteristics

Natural rubber latex sheath; teat-ended design; water-based warming lubricant. Conforms to ISO 4074 and ASTM D3492 standards.

Indications for Use

Indicated for use by individuals for contraception and the prevention of sexually transmitted diseases.

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 Warming Pleasure Latex Condom (K042957)
• KY Warming liquid personal lubricant (K021492)
• Invigra Male Latex Condom (K991374)

Submission Summary (Full Text)

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Page 1 of 2

K051273

AUG 1 9 2005

#### 510(k) Summary II.

| Submitted by: | Eagle TWE, Inc.<br>2090 Tucker Industrial Road, Suite A-5<br>Tucker, GA 30084 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bill Taffs<br>Phone [phone]<br>Fax [phone]<br>E-mail [e-mail] |
| Date Prepared: | May 12, 2005 |
| Proprietary Name: | Divas Dual Pleasure Male Latex Condom |
| Common Name: | Condom |
| Classification Name: | Condom (Rubber) Contraceptive |
| Predicate Device: | Durex Warming Pleasure Latex Condom<br>510K # K042957<br>KY Warming liquid personal lubricant<br>510K # K021492<br>Invigra Male Latex Condom<br>510K # K991374 |

510K # K984488

This condom is made of a natural rubber latex sheath, which Description of the Device: Description of the Device - The closely fitted membrane. The device is 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.

Intended Use of the Device: This latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. The warming condom lubricant has the same intended use as the predicate personal lubricants when used as an accessory to a condom. It relieves friction and facilitates ease and comfort of intimate sexual activity.

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Technological Characteristics: The latex condom has the same technological characteristics as a the predicate condom identified above. The condom described in K042957 are manufactured of natural rubber latex with the same shape as the condoms in this application. The competitor natural rubber latex with the same shape as the condoms with "The Printer ondoms with "Warm Sensation" lubricant to help enhance sexual pleasure.

The K-Y Warming liquid (K021492) is a water based, condom compatible personal lubricant on The K-Y Warming liquid (K021492) is a water based, consent on the warming lubricant on the Divas condom in this submission.

The condom design conforms to domestic and international regulations: ASTM D3942 and ISO The condom design conforms to donestic and international results in conformance with required specifications.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 9 2005

Mr. Bill Taffs President Eagle T.W.E., Inc. P.O. Box 1511 TUCKER GA 30085-1511 Re: K051273

Trade/Device Name: Diva's Dual Pleasure Male Latex Condom with Warming Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: August 8, 2005 Received: August 9, 2005

### Dear Mr. Taffs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave 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 the enorstate) to regary mant date of the Medical Device Amendments, or to devices that have been May 20, 1710, the chance 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 do not require to the general controls provisions of the Act. The general controls provisions of the Act actio, suojoet to the generation, 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 11 your a vise to the subject to such additional controls. Existing major regulations affecting your Approvatify to they of basyone 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 will allow you to begin marketing your intial equivalence of your device to a legally premarket notification. The IDA inding of substantial of a loves 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 device 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 Childer, "thisorial on your responsibilities under the Act from the 807.97). You may obtain other general informational and Consumer Assistance at its toll-free number (800) DIVISIOn of [phone] or at its Internet address 056-2011 01 \/www.fda.gov/cdrh/industry/support/index.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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# Divas Male Latex Condom with Warming Lubricant

Premarket Notification [510(k)] application

## Indications for Use Statement

510(k) Number:

051273________________________________________________________________________________________________________________________________________________________________________

\$

Device name:

Indications for Use:

Divas Dual Pleasure Latex Condom

The Divas Dual Pleasure condom is used for contraception The Divas Dual Ficasare poses to help prevent pregnancy and the transmission of sexually transmitted diseases.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
CONTI Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Cragdon

(Division Sign-Off) ive, Abdominal, Division of Reproduce Officiological Devices 310(k) Number