PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS

K060981 · Playtex Products, Inc. · HIL · May 9, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K060981
• Device Name: PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
• Applicant: Playtex Products, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: May 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

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

Device Story

Playtex Sport Plastic Tampons are menstrual hygiene products designed for the absorption of menstrual fluid. The device consists of an absorbent pledget and a plastic applicator. The applicator facilitates insertion into the vaginal canal. The device is intended for consumer self-use. The modified design features a contoured applicator and pledget shape, new fragrance, and updated colorants in the polyethylene resin of the applicator barrel and plunger. The device functions by absorbing menstrual fluid during use. It is marketed as both scented and unscented versions.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing including cytotoxicity, acute systemic toxicity, vaginal irritation, dermal irritation, allergic contact sensitization, microbial agar diffusion, and toxic shock syndrome toxin-1 (TSST-1) testing. Results indicate the modified device meets all safety and performance requirements.

Technological Characteristics

Menstrual tampon with absorbent pledget and plastic applicator. Materials include fiber and string identical to predicate. Applicator barrel and plunger composed of polyethylene resin with colorants. Features contoured applicator and pledget design. Scented and unscented variants available.

Indications for Use

Indicated for the absorption of menstrual fluid in individuals requiring menstrual hygiene products. Available for over-the-counter use.

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

• Playtex Non-deodorant & Deodorant Gentle Glide Tampons (K830966)
• Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons (K020201)
• Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons (K912002)

Submission Summary (Full Text)

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K06098i

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# 510(k) SUMMARY

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| Name of 510(k) sponsor: | Playtex Products, Inc. | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Address: | 75 Commerce Drive<br>Allendale, NJ 07401-1600<br>Telephone: | 201.785.8101<br>Facsimile:<br>201.785.8242 |
| Contact information: | Mr. Keith Edgett<br>Playtex Products, Inc.<br>Telephone:<br>Facsimile: | 302.678.6880<br>302.678.6540 |
| Date summary prepared: | April 7, 2006 | |
| Proprietary name of device: | Playtex Sport Plastic, Playtex Sport Plastic Multipack<br>Tampons | |
| Generic/classification name: | Scented and Unscented Menstrual Tampons | |
| Product code (classification): | Scented or scented deodorized menstrual tampons and<br>unscented menstrual tampons are Class II medical devices<br>(HIL, 21 C.F.R. § 884.5460 and HEB, § 884.5470,<br>respectively). | |

## Legally Marketed (Unmodified) Devices:

Playtex Non-deodorant & Deodorant Gentle Glide Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons

K830966, K020201, K912002

## Device Description:

Scented or scented deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

#### Intended Use:

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

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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#### Technological Characteristics:

The new tampon has the same technological characteristics as the cleared tampon. The fiber, string, and materials in contact with the vaginal wall are the same or have the same mode of action. The only differences in the modified tampons from the predicate devices are: the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger; a new fragrance; and the contoured shape of the applicator and pledget.

#### Performance Data:

Cytotoxicity testing, acute systemic toxicity testing, vaginal irritation testing, dermal irritation, allergic contact sensitization tests, microbial agar diffusion and toxic shock syndrome toxin-1 (TSST-1) testing indicate that the modified device meets all device input requirements.

#### Conclusions:

The modified Playtex tampons are substantially equivalent to the predicate tampons.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY - 9 2006

Mr. Keith Edgett Vice President Playtex Products, Inc. 75 Commerce Drive ALLENDALE NJ 07401

Re: K060981

Trade/Device Name: Playtex Sport Plastic Tampons, Unscented and Playtex Sport Plastic Tampons, Fresh Scent

Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL Dated: April 7, 2006 Received: April 11, 2006

Dear Mr. Edgett:

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.

Image /page/2/Picture/11 description: The image shows the FDA Centennial logo. The logo is circular and contains the letters "FDA" in bold, black font. The words "Centennial" are written below the letters "FDA". The years "1906-2006" are written at the top of the circle.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEAS or advised that I DA's Issuance of a saceannal of the requirements of the Act or any FDA has made a decemination that your devices. You courses. You must comply with all
Federal statutes and regulations administered by other Federal agencies. CON CEP Re-1 807 Federal statutes and regulations administered of Ourse to registration and listing (21 CFR Part 807); the Act s requirements, mending, vat not mined to very career equirements as set forth in the quality labeling (21 CFR Part 001), good manalastians Fapplicable, the electronic product radiation in control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification: "The PDA midnig of backannal vour 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 advice for your correst on 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 Also, please note the regulation other general information on your responsibilities under the Act from CI N 601.97). Tod may obtain outs. Beternational 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

KO60981

510(k) Number (if known):

Playtex Products, Inc.

Device Name:

Indications For Use:

Playlex Sport Plastic Tampons, unscented Playtex Sport Plastic Tampons, fresh scent

Playtex Sport Plastic Tampons (unscented/fresh scent) for the absorption of menstrual fluid.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sign-Off) / Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

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