FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS

K032173 · First Quality Hygienic, Inc. · HIL · Sep 3, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K032173
• Device Name: FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
• Applicant: First Quality Hygienic, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Sep 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

First Quality Hygienic Femtex and Other Private Label Scented Plastic Applicator Tampons, a Class II device, are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Device Story

Menstrual tampons with plastic applicators; used to absorb menstrual fluid or vaginal discharge. Available in four absorbencies: Junior, Regular, Super, and Super Plus. Contains fragrance for aesthetic purposes. Intended for over-the-counter use by patients. Device functions via physical absorption of fluids.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including Syngyna absorbency testing and biocompatibility assessments (irritation, cytotoxicity, sensitization, and vaginal irritation testing).

Technological Characteristics

Materials: rayon absorbent, cotton cord, cotton sewing thread, added fragrance. Form factor: tampon with plastic applicator. Absorbency levels: Junior, Regular, Super, Super Plus. Energy source: none (mechanical).

Indications for Use

Indicated for use by individuals requiring absorption of menstrual or other vaginal discharge.

Regulatory Classification

Identification

A scented or scented deodorized menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. It has scent (i.e., fragrance materials) added for aesthetic purposes (scented menstrual tampon) or for deodorizing purposes (scented deodorized menstrual tampon). This generic type of device does not include menstrual tampons treated with added antimicrobial agents or other drugs.

Submission Summary (Full Text)

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## SEP - 3 2003

## ¥032173 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 Private label Plastic Applicator tampons.

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 with 4 absorbencies, Junior, 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.

- 0 irritation testing
- 0 cytotoxicity testing
- � sensitization testing
- 0 vaginal irritation testing

***

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Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings. The logo is black and white and appears to be a seal or emblem.

Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850

SEP - 3 2003

First Quality Hygienic, Inc. % Robert J. Staab, Ph.D. Official Correspondent Regulatory and Technical Associates 73 Franklin TPK ALLENDALE NJ 07401

Re: K032173

Received: July 21, 2003

Trade/Device Name: Femtex and Other 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: July 14, 2003

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.

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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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.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

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510(k) Number (if known): Ko3217 3

First Quality Hygienic Femtex and Other Private Label Scented Device Name: Plastic Applicator Tampons_

Indications for Use; Statement of Indications for Use: As defined in 21 CFR 884.5460 and 21 CFR 884.5470, First Quality Hygienic Femtex and Other Private Label Scented Plastic Applicator Tampons, a Class II device, are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

David G. Legmann

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices KA32173
510(k) Number

Over-The-Counter Use