FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES

{0}------------------------------------------------ K023479 # NOV 2 6 2002 ### 510K SUMMARY # Device Name: "Femtex" Tampons and other Private Label Plastic Applicator Tampons VII Legally marketed device: These Tampons are substantially equivalent to legally marketed predicate tampons with applicators. Device description: First Ouality Hygienic Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in four absorbencies: junior regular, super and super plus. These Tampons are made from rayon and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US. Intended Use: These 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 and safety evaluations of tampon components were historically carried out. The results of these tests demonstrate that these 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 of raw materials were historically conducted and are relevant to the safety of First Quality Hygienic plastic applicator tampons. - ◇ irritation testing - 0 sensitization testing - 0 acute oral toxicity - � eve irritation testing - cytotoxicity testing ◇ *** {1}------------------------------------------------ # Menstrual Tampon #### VIII Substantial Equivalence Comparison Chart | Comparison Element | New device | Predicate Device | |---------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Device Name | First Quality HygienicPrivate label<br>plastic<br>applicator tampons | Kotex plastic<br>applicator<br>tampons | | Manufacturer | First Quality Hygien.. | Kimberly Clark | | 510 (k) # | requested | K896994 | | Intended Use | Absorb Menses<br>Intravaginally | Absorb Menses<br>Intravaginally | | Device Design | spec.<br>Junior 1.80 g 35mm<br>Reg. 2.20g, c.44mm<br>Sup. 3.30 g c. 45 mm<br>SupPl. 3.6 g, 53 mm<br>cord, 125 mm (all) | Kotex est.<br>Reg 2.30 g, 42 mm<br>Sup. 3.30 g, 45 mm<br>SupPl.c.4.4g, 55 mm<br>cord, 130 mm (all) | | Component Materials | plug:rayon<br>PEG stearate palmitate, or<br>polyoxyethylene 20<br>sorbitan monolaurate | plug: rayon/cotton mix<br>fatty acid polyglycol<br>ester/fatty alcohol poly-<br>glycol ether, Leomin,<br>glycerol finishes | | | sewing thread: cotton | sewing thread: cotton | | wax | w/drawal cord: cotton<br>w/ paraffinic wax base | w/drawal cord: cotton<br>w/ paraffinic<br>base | | Applicator | food grade polyethylene<br>linear | food grade<br>polyethylene<br>linear mix | મિન્મનીપાઝ {2}------------------------------------------------ Absorbency range in grams per Syngyna methodology | | junior | regular/ | super | super plus | |-------------------------------|--------|----------|-------|------------| | maximum | 6 | 9 | 12 | 15 | | minimum | - | 6 | 9 | 12 | | required accessory<br>devices | none | none | none | none | | Other features | none | none | none | none | {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and head. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the bird. NOV 2 6 2002 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 Frankllin TPK ALLENDALE NJ 07401 Re: K023479 Trade/Device Name: "Femtex" Tampons and other Private Label Plastic Applicator Tampons Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: October 17, 2002 Received: October 17, 2002 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 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 (PMA), it may be subject to 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. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 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: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Snogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Page_ 2012 510(k) Number (if known): 长安33479 Arsieris no of Device Name: ERSS Quariel Plastic Applicaron Indications For Use: ## INDICATIONS FOR USE As a Class II device, the menstrual tampon is defined as follows: (21 CFR 884.5460 and 21 CFR 884.5470). > First Quality Hygienic plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Segeum (Division Sign-off) Reproductive, Abdominal Over The Counter Prescription Use (Per 21 CFR 801