SAN-MAR LABS LUBRICATING JELLY

{0}------------------------------------------------ # 510(k) Summary K041667 # I. General Information on Submitter | Name: | San-Mar Laboratories, Inc. | |-----------------|----------------------------------------| | Address: | 4 Warehouse Lane<br>Elmsford, NY 10523 | | Telephone: | 914.592.3130 | | Fax: | 914.592.5373 | | Contact Person: | Simon Sanders | | Date Prepared: | June 15, 2004 | #### II. General Information on Device Name: San-Mar Laboratories Lubricating Jelly Classification Name: Patient Lubricant #### III. Predicate Device K-Y® Lubricating Jelly ### IV. Description of Device The device is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone. glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. #### V. Intended Use The San-Mar Labs Lubricating Jelly is intended for personal lubrication when vaginal dryness causes discomfort and as a lubricant for insertion of rectal thermometers, enemas, douches, and similar types of nozzles. # VI. Technological Characteristics of Device Compared to Predicate Device The technological characteristics of the San-Mar Labs Lubricating Jelly are identical to those of the predicate device. ## VII. Summary of Performance Data Stability of the San-Mar Labs Lubricating Jelly was confirmed throughout its labeled shelf life (36 months) by a 36 month long-term stability study and a preservative effectiveness test in accordance with USP method <51>. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, symbolizing care and protection. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter. The logo is rendered in black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Simon Sanders Director of Quality San-Mar Labs, Inc. 4 Warehouse Lane ELMSFORD NY 10523 Re: K041667 JAN 1 3 2005 Trade/Device Name: San-Mar Laboratories Lubricating Jelly Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II ---Product Code: 85 HIS Dated: October 22, 2004 Received: October 28, 2004 Dear Mr. Sanders: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the 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 reclassified in accordance with 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 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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. {2}------------------------------------------------ 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.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 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 (301) 443-6597 or at its 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): Kort 1667 KY Type Lubricating Jelly Device Name: Indications for Use: Use Lubricating Jelly to lubricate condoms and for personal lubrication when vaginal dryness causes discomfort. It also eases insertion of rectal thermometers, enemas, and tampons. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR 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) Tancyc Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, nd Radiological Device 510(k) Number _ Page 1 of 1