UNDUS MALE LATEX CONDOM (WITH FLAVORING)

K023176 · Unidus Corp. · HIS · Dec 13, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K023176
• Device Name: UNDUS MALE LATEX CONDOM (WITH FLAVORING)
• Applicant: Unidus Corp.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Dec 13, 2002
• 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 condom. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases, including HIV.

Device Story

Male natural rubber latex condom; straight-walled with reservoir tip; nominal length 180-mm, width 52-mm, thickness 0.06-mm. Lubricated with silicone containing one of five flavors (strawberry, mint, vanilla, banana, or chocolate); cornstarch used as dressing material. Device covers erect penis to provide physical barrier. Used by consumers for contraception and STI prevention.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and adherence to established national and international voluntary standards (ASTM D3492 and ISO 4074).

Technological Characteristics

Natural rubber latex sheath; straight-walled with reservoir tip; 180-mm length, 52-mm width, 0.06-mm thickness. Lubricated with flavored silicone; cornstarch dressing. Conforms to ASTM D3492 and ISO 4074 standards.

Indications for Use

Indicated for use by individuals for contraception and as a prophylactic to help prevent pregnancy and the transmission of 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

• Remed Pharma Flavored Latex Condom (K993403)

Submission Summary (Full Text)

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# K023176

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

| II. | 510(k) SUMMARY | | |
|-----|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Submitted By: | UNIDUS Corporation<br>Seokyung Bldg., 51 Bang-1 Dong<br>Songpa-Ku<br>Seoul, Republic of Korea | DEC 13 2002 |
| | Contact Persons: | Eli J. Carter<br>Consultant to UNIDUS Corporation<br>1219 Little Creek Road<br>Durham, NC 27713 | H.S. Lee<br>Managing Director<br>UNIDUS Corporation<br>Seokyung Building 51,<br>Bangi-Dong, Songpa-Ku<br>Seoul, Korea |
| | Date Prepared: | September 12 , 2002 | |
| | Proprietary Name: | UNIDUS; (and other private label brands) | |
| | Common Name: | Male Latex Condom (w/Flavored Lubricant) | |
| | Classification Name: | Male Latex Condom | |
| | Predicate Device: | Remed Pharma Flavored Latex Condom - 510(k) 993403 | |
| | Description of Device: | This condom is made of a natural latex sheath, which completely<br>covers the erect penis with a closely fitted membrane. This condom is<br>straight-walled with a reservoir tip; nominal length 180-mm, nominal<br>width 52-mm, and nominal thickness 0.06mm. It is lubricated with<br>silicone containing one of five flavors (strawberry, mint, vanilla,<br>banana, or chocolate) and cornstarch is used as a dressing material.<br>This condom is designed to conform to established national and<br>international voluntary standards including ASTM D3492 and ISO<br>4074. | |
| | Intended Use of the Device: | This latex condom has the same intended use as the predicate condom.<br>The condom is used for contraception and for prophylactic purposes to<br>help prevent pregnancy and the transmission of sexually transmitted<br>diseases, including HIV. | |
| | Technological Characteristics: | This condom has the same technological characteristics as the predicate<br>condom identified above. The design is in conformance with ASTM<br>Latex Condom Standard D3492 and that the condom is made of natural<br>rubber latex. | |

..

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FC. 1 3 2002

Unidus Cororation % Mr. Eli J. Carter Consultant 1219 Little Creek Road DURHAM NC 27713

Re: K023176

Trade Name/Device: Male Natural Rubber Latex Condom with flavored lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 12, 2002 Received: September 23, 2002

Dear Mr. Carter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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This letter will allow you to begin marketing your device as described in your 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.

Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and 8884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in §801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, \$801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in §801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [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" (21 CFR §807.97). 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/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Ernst A. Lygum

for

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health cc: HFZ-401

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K02-3176

#### Information for a Male Latex Condom 510(k) Submission

Page 11 of 13

#### VII. INDICATIONS FOR USE STATEMENT

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

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

Prescription Use OR Over-the-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023176