UNIDUS MAGNUM MALE LATEX CONDOM

K072747 · Unidus Corp. · HIS · Nov 15, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K072747
• Device Name: UNIDUS MAGNUM MALE LATEX CONDOM
• Applicant: Unidus Corp.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Nov 15, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The UNIDUS condom is used for contraceptive and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.

Device Story

Natural rubber latex sheath; straight-walled with reservoir tip; lubricated with silicone; cornstarch dusting. Designed for men requiring larger size (205mm length, 57mm flat width). Used for contraception and prevention of sexually transmitted diseases. Device functions as physical barrier.

Clinical Evidence

Bench testing only. Device conforms to ASTM D3492 and ISO 4074 standards.

Technological Characteristics

Natural rubber latex sheath; straight-walled with reservoir tip; 205mm length, 57mm flat width, 0.06mm thickness. Lubricated with silicone; cornstarch dusting. Conforms to ASTM D3492 and ISO 4074 standards.

Indications for Use

Indicated for men for contraception and prophylaxis to help prevent pregnancy and sexually transmitted diseases, including HIV.

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

• Carter-Wallace Version One Trojan Extra Large Latex Condom (K001212)

Submission Summary (Full Text)

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K072747

## Abbreviated 510(k) Notification for Magnum Male Latex Condom

Page 5 of 13

### II. 510(k) SUMMARY

| Submitted by: | UNIDUS Corporation<br>Seokyung Building 51, Bangi-Dong<br>Songpa-Ku<br>Seoul, Republic of Korea | NOV 15 2007 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Persons: | Claude L. Wright<br>Consultant to UNIDUS Corp.<br>507 Shallow Creek Road<br>Tuscaloosa, Alabama 35406<br>Telephone: [phone]<br>Email: [e-mail] | Sung Hoon Kim<br>President<br>UNIDUS Corporation<br>Seokyung Building 51,<br>Bangi-Dong<br>Songpa-Ku, Seoul, Korea<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 27, 2007 | |
| Proprietary Name: | UNIDUS or Private Label | |
| Common Name: | Male Latex Condom | |
| Classification Name: | Male Latex Condom | |
| Predicate Device: | Carter-Wallace Version One Trojan Extra Large Latex Condom | |

With silicone lubricant 510(k) number K001212

Description of Device:

This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 205mm, nominal flat width 57mm, and nominal thickness 0.06mm. It is lubricated with silicone and cornstarch is used as a dression material. This condom is designed to conform to established. national and international voluntary standards including ASTM D3492 and ISO 4074.

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

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prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.

Technological Characteristics:

This condom has the same technological characteristics as the predicate condom identified above. The design is in conformance with ASTM Latex Condom Standard D3492 and the condom is made from the same natural rubber latex compound as listed in UNIDUS 510(k) number K023059 along with using the same production equipment. The Magnum Latex Condom is designed with a longer length of 205mm and wider flat width of 57mm for the man who needs a larger size condom.

The UNIDUS Magnum Latex Condom is intended for men who feel that current regular size condoms are too small.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing a family or community, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1-5 2007

Mr. Claude L. Wright Consultant to UNIDUS Corporation 507 Shallow Creek Road TUSCAL00SA ALABAMA_35406

Re: K072747

Trade Name: UNIDUS or Private Label Regulation Number: 21 CFR §884.5300 Regulation Name: condom Regulatory Class: II Product Code: HIS Dated: September 27, 2007 Received: September 27, 2007

Dear Mr. Wright:

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 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/cdrb/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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### INDICATIONS FOR USE STATEMENT VII.

| 510(k) Number | Not Known K072747 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Male Natural Rubber Latex Condom |
| Indications for Use: | The UNIDUS condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). |

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

Prescription Use (Per 21 CFR 801.109)

or

Over-the-Counter Use_

V

Julius Remer

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_ |< 0 7 2-7 L