POWERSTICK MALE LATEX CONDOMS

{0}------------------------------------------------ 041717 JAN 1 3 2005 ## II. 510(k) SUMMARY | Submitted By: | A.P. Deauville, LLC.<br>594 Jersey Ave.<br>New Brunswick, NJ 08901<br>(732) 545-0200 | |----------------------|--------------------------------------------------------------------------------------| | Contact Person: | Scott L. Baier | | Date Prepared: | June 23, 2004 | | Proprietary Name: | Power Stick® Male Latex Condoms | | Common Name: | Male Latex Condom | | Classification Name: | Condom (21 CFR §884.5310) | | Predicate Device: | Male Latex Lubricated Condom [510(k)<br>Number K040185] | Description of the Device:_This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. These two types of condoms, ribbed and dotted-ribbed, are at a nominal length of 170mm., a nominal width of 52 mm (±2mm) and are at a nominal thickness of .06 mm (±.02 mm). Intended Use of the Device: 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). Technological Characteristics: This design is in conformance with ASTM Latex Condom Standard D3492 and that the condom is made of natural rubber latex and has the same technological characteristics as the predicate condoms identified [510(k) Number K040185]. The condoms described in K040185 are manufactured ribbed and dotted/ribbed Natural Rubber Latex male condoms with a silicone lubricant. The condom design conforms to domestic and international regulations: ASTM D3942, ISO 4074 and EN 600. All physical testing and final release testing revealed in conformance with required specifications. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Scott L. Baier Operations Manager A. P. Deauville, LLC 594 Jersey Avenue NEW BRUNSWICK NJ 08901 Re: K041717 Trade/Device Name: Power Stick® Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II - -Product Code: 85 HIS Dated: December 15, 2004 Received: December 27, 2004 Dear Mr. Baier: We have reviewed your Scction 510(k) premarket notification of intent to market the device referenced we have reviewed your readle 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 reasy 20, 1976, the other with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reculssitied in accessal of a premarket approval application (PMA). You may, therefore, market the do inc. 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 n your al), it may be subject to such additional controls. Existing major regulations affecting your I ipply rary we found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I toase of a would 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 (2) CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (2) Crice (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. JAN 1 3 2005 {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will andw you to ocgin manteing your and equivalence of your device to a legally premarket nothication. The I DA Inting of Sacsamal Price 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 If you desire specific advice ior your cerrest on wind wind of the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation entires), formation on your responsibilities under the Act from the 807.97). Tou may obtain other general international and Consumer Assistance at its toll-free number (800) DVISION 01 311all Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K041717 Device Name: Power Stick Male Latex Condoms Indications For Use: The Power Stick Male Latex Condom is used for controptive fic fower belen cric purposes (to help prevent pregnancy and for prophylaction of sexually transmitted diseases). Prescription Use (Part 21 CFR 801 Subpart D) AND/OR XXX Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Yancey Gordon (Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number Page 1 of 1 _