DUREX ULTRA COMFORT

K980319 · London Intl., LLC · HIS · May 20, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980319
• Device Name: DUREX ULTRA COMFORT
• Applicant: London Intl., LLC
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A Latex Rubber Condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.

Device Story

Latex rubber condom designed for wear over male penis during vaginal intercourse. Acts as physical barrier to prevent pregnancy and transmission of sexually transmitted diseases. Device is for over-the-counter use by general population. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data provided; device relies on established material safety and performance characteristics for latex condoms.

Technological Characteristics

Latex rubber material. Physical barrier form factor. No energy source, connectivity, or software components.

Indications for Use

Indicated for use by males during vaginal intercourse to prevent pregnancy and the transmission 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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1998

Mr. Neil Anderson, RAC Director of Regulatory Affairs London International Group plc (LIG) P.O. Box 8308 2926 Columbia Highway Dothan, AL 36303

Re: K980319

Durex® Ultra Comfort Latex Rubber Condoms Dated: April 29, 1998 Received: April 30, 1998 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS

Dear Mr. Anderson:

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 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, against misbranding and adulteration.

If your device is classified (see above) into either class II (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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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 Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):

Device Name: Latex Rubber Condom

Indications For Use:

A Latex Rubber Condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread 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)

Robert R. Selling
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K980319

Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801.109)

Over-The-Counter Use V

(Optional Format 1-2-96)