(315 days)
The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.
The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut flavor and no color additives.
This document is a 510(k) clearance letter from the FDA for a condom, and it does not contain the specific information required to answer the questions about acceptance criteria and a detailed study.
Therefore, I cannot provide the requested information from this document.
To answer your questions, I would need access to a study report or a different type of FDA submission that details the performance data and acceptance criteria for a medical device. This document primarily confirms that the device is substantially equivalent to a predicate device, allowing it to be marketed.
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Image /page/0/Picture/0 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 a bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2000
Remed Pharma c/o E. J. Smith Smith Associates P.O. Box 4341 Crofton, MD 21114 Re: K993409 Remed Pharma Male Banana Tutti Frutti Natural Rubber Latex Condom Dated: July 10, 2000 Received: July 11, 2000 Requiatory Class: II 21 CFR 884.5300/Procode: 85 HIS
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device and we have getermined the We have reviewed your Section 510(K) noticalions for use stated in the endos reditate devices and device is substantially equivalent (10 the nates in the endotal of orgalic of the Medical Perice Areners, or to devices that marketed in interstate commerce proc to May 26, 1976, the enders one model oneits Art (Act). You may, therefore,
have been reclassified in accordance with the provisions of have been reclassified in accordance with the provisions of the Act. The general convisions of the Act Includes of the Act Include market the device, subject to the general controls provisions of the general control of the end of the end of the mail of the and adulteration.
If your device is classified (see above) into either class III (Special Controls) in the Code of Federal Regulations. Title 2 lf your device is classified (see above) into elitection your device can be Code of Federal Regulation, Title 21,
such additional controls. Existing major regulations affec such additional controls. Extrang major regulations and Servit the Current Good Manufacturing Pracio.
Parts 800 to 895. A substantially equivalent delemination assumes neg Parts 800 to 895. A substantally equivalent delemination in assults overal resultsion (21 CFR Pat 820), and requirements, as set forth in the Qualif (QS) in Reden Brillen Bonnel (server stock socknown). Fallure to ormply will that, through periodic US inspections, the Fod and Drug Forminstation of the movements concerning your device in the GMP regulation may result in regulation in artistic notification submitssion does and after any obligation, you might the Federal Register. Please note: this response to your pennation backless of the Subscription of the Provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) prematies in vour device and hus This letter will allow you to begily marketed predicate device in your over 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 Pat 801 and additionally for questions on the mombination lf you desire specific advice for your device of Our (21 v. 14). Additionally (econvestions on the promotions on the promotion and diagnostic devices), please contact the of Compliance at (301) 694-639. Also, please note the regulation entiled.
advertising of your device, please contact the of Compline advertising of your device, please contact the Off of Post and interprises wour resording under the mode the "Misbranding by releence to perflaked nources in Cor. ST/P - Cher goller (Mornal Mornet More on Pool (800) 63-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html"
Sincerely yours,
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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510(K) Number (if known): K993409
Device Name: Remed Pharma Male Coconut Tutti Frutti Natural Rubber Latex Condom
Indications for Use:
The Remed Preventor Coconut Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Coconut Tutti Frutti condom is a parallel sided, plain surfaced condom with coconut flavor and no color additives. It is used for contraception and to help prevent 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
Over-the-Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K993409
§ 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.