NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal lines above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 ## OCT - 5 2006 Sri Mahendra Sathiacama General Manager Biogreen Medical Sdn. Bhd. Lot 138201, Off ¼ Mile Jalan Bercham, Kawasan Eot 150201, Bercham, Ipoh Perak 31400, Malaysia Re: K062730 R002750 Trade/Device Name: Male Natural Rubber Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Non-Spermicidal Male Latex Condom Regulatory Class: II Product Code: HIS Dated: Sept. 1, 2006 Received: Sept. 13, 2006 Dear Sri Sathiacama: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally breaks is substantially equivalent (for the indications for referenced above and nave acteminar arteted predicate devices marketed in interstate commerce use stated in the enorobard to regard that of the Medical Device Amendments, or to devices that proof to way 20, 1770, and claims. and 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 increisions of the Act include requirements for annual registration, listing of devices, good Condors provisions of also not morade prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is classinos (500 additional controls. Existing major regulations affecting your Apploval), it thay be subject to Judi adant Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/0/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are in the center of the seal. There are three stars below the word "Centennial". The seal appears to be a commemorative emblem for the centennial of the Food and Drug Administration. Protecting and Promoting Public Health {1}------------------------------------------------ Page 2 - 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely vours. Nancy C. Hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## VII. INDICATIONS FOR USE STATEMENT 510(k) Number: K062730 name] Device Name: Male Natural Rubber Latex Condom [No particular brand Indications For Use: The [No particular brand name] condom is used for contraception 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 David le Hyrm (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.