FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS

K051446 · First Quality Hygienic, Inc. · HIL · Jul 14, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K051446
• Device Name: FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
• Applicant: First Quality Hygienic, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Jul 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

First Quality Hygienic, Inc. Femtex and Private Label Scented plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Device Story

Device consists of menstrual tampons with plastic applicators; available in five absorbency levels (Light, Slender Regular, Regular, Super, Super Plus). Composed of rayon absorbent, cotton cord, and cotton sewing thread with added fragrance. Used by patients for menstrual fluid absorption. Safety established via biocompatibility testing (sensitization, vaginal irritation) and Syngyna absorbency testing.

Clinical Evidence

No clinical data. Evidence based on non-clinical bench testing, including biocompatibility (sensitization and vaginal irritation) and standard Syngyna absorbency testing.

Technological Characteristics

Materials: rayon absorbent, cotton cord, cotton sewing thread, added fragrance. Form factor: tampon with plastic applicator. Five absorbency levels. Non-sterile.

Indications for Use

Indicated for use by females for the 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.

Predicate Devices

• Femtex and Other Private label Scented Plastic Applicator tampons (K032173)

Submission Summary (Full Text)

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## KOS1446

JUL 1 4 2005

## 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.

- sensitization testing �
- vaginal irritation testing �

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

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: K051446

JUL 1 4 2005

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: HIL Dated: May 31, 2005 Received: June 29, 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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you'to organization of substantial equivalence of your device to a legally premarket notification: "The PDF mining of Station 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 active for your 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 enners information on your responsibilities under the Act from the 807.77). Tournal Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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## Indications for Use

KOS1446 510(k) Number (if known):_Applied for

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 plastic applicator tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb 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)

Nancyc hogdon
(Division Sign-Off)

Division of Reproductive, Abdom and Radiological Devic " (k) Number,

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