(205 days)
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 the spread of sexually transmitted diseases.
Not Found
I am sorry, but the provided text is a letter from the FDA regarding the clearance of Durex Colors and Scents Latex Rubber Condoms (K980174). It does not contain information about acceptance criteria, study details, or performance data for a device in the manner requested by your prompt (e.g., sample sizes, expert qualifications, ground truth, or MRMC studies).
The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indications of preventing pregnancy and the spread of sexually transmitted diseases. However, it does not provide the specific technical acceptance criteria or the study data that would demonstrate how the device meets such criteria.
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Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bodies, representing the three branches of government. The text "HUMAN SERVICES - USA" is visible at the top of the logo, and "DEPARTMENT OF HEA" is visible on the left side.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1998
Mr. Bradley L. Pugh Vice President, Scientific Affairs London International Group, LLC U.S. Research and Development P.O. Box 8308 Dothan, AL 36304
Re: K980174 Durex Colors and Scents, Latex Condoms with Lubricant and Fragrance Additives Dated: July 8, 1998 Received: July 9, 1998 Regulatory Class: II 21 CFR 884.5300/Procode: 85 HIS
Dear Mr. Pugh:
We have reviewed your Section 510(k) notification of intent to market the device 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, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 (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 531 through 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 vitio diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmaldsmam.html".
Sincerely your
Lillian Yin, Ph.D.
Director, Division of Reproductive, 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): K980174
Device Name: Durex Colors and Scents Latex Rubber Condoms
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 the 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)
Colin M. Pollard
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K980174
Prescription Use (Per 21 CFR 801.109) ેવાયું છત્વ
Over-The-Counter Use
(Optional Format 1-2-96)
§ 884.5300 Condom.
(a)
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.(b)
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.