FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS

{0}------------------------------------------------ ## KOSOO67 ## 510K SUMMARY Device Name: Femtex and Private Label Scented Plastic Applicator Tampons Legally marketed device: These Femtex and Private Label Scented Plastic Applicator Tampons are substantially equivalent to legally marketed Femtex and Other Private label Scented Plastic Applicator tampons (K032173). Device description: Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided in five (5) styles/absorbencies: Light, Slender Regular, Regular, Super and Super Plus with a plastic applicator. Femtex and Private Label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance. The material used in Femtex and Private Label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons. Intended Use: Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid. ## Assessment of Performance Standards: Not Applicable Non-Clinical Testing: Biocompatibility testing of the Femtex and Private Label Scented Plastic Applicator Tampons was reviewed. The results of these tests demonstrate that the tampons are equivalent in terms of safety and effectiveness to legally marketed tampons. Standard Syngyna testing confirmed the absorbency of these tampons. In addition to the review of existing toxicological data in the public literature, the following tests have been conducted on components relevant to the safety of Femtex scented plastic applicator tampons. - irritation testing � - cytotoxicity testing 0 - sensitization testing 0 - vaginal irritation testing 0 *** {1}------------------------------------------------ Image /page/1/Picture/13 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with its wings spread. The image is in black and white and appears to be a logo or emblem. Image /page/1/Picture/3 description: The image shows the text 'FEB - 1 2005' in a simple, sans-serif font. The text is arranged horizontally, with 'FEB' on the left, followed by a hyphen, the number '1', and the year '2005'. The text appears to be a date, indicating February 1, 2005. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 First Quality Hygienic, Inc. % Robert J. Staab, Ph.D. Official Correspondent Regulatory and Technical Associates 73 Franklin TPK. ALLENDALE NJ 07401 Re: K050067 Trade/Device Name: Femtex and Private Label Scented Plastic Applicator Tampons Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: 85 HIL Dated: January 10, 2005 Received: January 12, 2005 Dear Dr. Staab: 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 the enerosale) to regally manned ate of the Medical Device Amendments, or to devices that have been rear 20, 1770, the clarians 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 do not require approvince of a 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 If your de rio is classino controls. Existing major regulations affecting major regulations affecting your Approval), It may of cashes to and Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA as roo ban of round announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I loase be advisod that i breat your device complies with other requirements of the Act or any I DA has made a decemination and your evel by other Federal agencies. You must comply with all the I cacal statues and regalding, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, metaling practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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) This letter will anow you'lo orgin mating of substantial equivalence of your device to a legally premarked nothleation: "The PDF mailing sification 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 If you desire specific act 100 for your as on 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 Also, prease note the regulation on your responsibilities under the Act from the 807.77). Tou may obtain varers, International and Consumer Assistance at its toll-free number (800) DVISION of Offair Manakatarers, ins Internet address http://www.fda.gov/cdrh/dsmadsmamain.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): Applied for K O 5 0 06 7 Device Name: First Quality Hygienic, Inc. Femtex and Private Label Scented Plastic Applicator Tampons Indications For Use: As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470). First Quality Hygienic, Inc. Femtex and Private Label Scented plasted into the the the First Quality Hyglenic, Inc. I Cintox and that is inserted into the vagina tampons are a play menstrual or other vaginal discharge. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy Bridgon (Division Sign-Off) (Division of Reproductive, Abdom and Radiological Device 510(k) Number . Page 1 of