PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)

K032636 · Playtex Products, Inc. · HEB · Nov 14, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K032636
• Device Name: PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
• Applicant: Playtex Products, Inc.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Nov 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Playtex tampons are intended to be used as unscented menstrual tampons for the absorption of menstrual fluid.

Device Story

Unscented menstrual tampons with cardboard applicators; designed for absorption of menstrual fluid. Device utilizes same fiber, string, and vaginal-contact materials as predicate. Used by consumers for personal menstrual hygiene. No electronic or mechanical processing involved.

Clinical Evidence

Nonclinical testing performed, including sensitization, acute oral toxicity, subacute vaginal irritation, agar diffusion, and TSST-1 toxin testing. No clinical human trials reported.

Technological Characteristics

Unscented menstrual tampon with cardboard applicator. Materials (fiber, string) identical to predicate. Class II device. No electronic components or software.

Indications for Use

Indicated for use by menstruating individuals for the absorption of menstrual fluid.

Regulatory Classification

Identification

An unscented 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. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

Predicate Devices

• Playtex SilkGlide® Odor-Absorbing Cardboard Applicator Tampons (K981760)

Submission Summary (Full Text)

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K632636

NOV 1 4 2003

# 510(k) SUMMARY

| Name of 510(k) Sponsor: | Playtex Products, Inc. |
|------------------------------|-------------------------------------------------------------------------------|
| Address: | 75 Commerce Drive<br>Allendale, New Jersey 07401 |
| Telephone:<br>Fax: | [phone]<br>[phone] |
| Contact Person: | Karen A. Costa, Ph.D.<br>Director, Regulatory, Safety &<br>Biomedical Affairs |
| Date of Summary: | August 25, 2003 |
| Proprietary Name of Device: | Playtex Tampons #13203 & #13203PV |
| Generic/Classification Name: | Unscented menstrual tampon |

## Legally Marketed Predicate Devices:

Playtex SilkGlide® Odor-Absorbing Cardboard Applicator Tampons (K981760).

## Device Description and Technological Characteristics:

Unscented menstrual tampons for the absorption of menstrual fluid. The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginat wall are the same or have the same mode of action.

### Intended Use:

Playtex tampons are intended to be used as unscented menstrual tampons for the absorption of menstrual fluid.

## Testing:

Clinical and nonclinical testing conducted included sensitization, acute oral toxicity, subacute vaginal irritation, agar diffusion and TSST-1 toxin testing. Based on these data, it can be concluded that the Playtex #13203PV tampons are substantially equivalent to the predicate device in terms of safety and effectiveness.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2003

Karen A. Costa, Ph.D. Director, Regulatory & Biomedical Affairs Playtex Products, Inc. Technical Center 75 Commerce Dr. ALLENDALE NJ 07401-1600 Re: K032636

Trade/Device Name: Playtex® Unscented Cardboard Applicator Tampon #13203(colored) and #13203PV(non-colored) Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: 85 HEB Dated: August 25, 2003 Received: August 28, 2003

Dear Dr. Costa:

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 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 (OS) 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/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

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# INDICATIONS FOR USE STATEMENT

| Applicant: | Playtex Products, Inc. |
|---------------------------|-----------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K032636 |
| Device Name: | Playtex® Unscented Cardboard Applicator Tampon<br>#13203 (colored) and #13203PV (non-colored) |
| Indications for Use: | unscented tampons for the absorption of menstrual fluid |

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | or | Over-the-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

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| Division of Reproductive, Abdominal,<br>and Radiological Devices | Page 18 |
| PROPRIETARY DOCUMENT and information contained herein may not be reproduced, used or disclosed without written permission of Playtex Products, Inc. | |
| 510(k) Number | K032636 |