MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS

K070745 · Playtex Products, Inc. · HIL · Apr 13, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070745
• Device Name: MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
• Applicant: Playtex Products, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Apr 13, 2007
• 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 Gentle Glide Plastic and Multipack Tampons are menstrual hygiene devices designed for the absorption of menstrual fluid. The device consists of a formed pledget and an applicator. The pledget is inserted into the vaginal canal to absorb fluid. The device is intended for over-the-counter use by individuals during menstruation. The modified device features updated colorant compositions in the polyethylene resin used for the applicator barrel and plunger, and adjusted dimensions for the unformed pledget pads, while maintaining the same functional mode of action as predicate devices.

Clinical Evidence

Bench testing only. Testing included 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 device input requirements.

Technological Characteristics

Materials include polyethylene resin (applicator barrel and plunger), fiber, and string. The device utilizes a pledget for fluid absorption. No electronic components or software. Sterilization method not specified.

Indications for Use

Indicated for the absorption of menstrual fluid in individuals requiring menstrual hygiene products. Available as scented, scented deodorized, or unscented tampons.

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

Submission Summary (Full Text)

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K010745

# 510(k) SUMMARY

| Name of 510(k) sponsor: | Playtex Products, Inc. | APR 13 2007 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Address: | Playtex Products, Inc.<br>804 Walker Rd.<br>Dover, DE 19904<br>Telephone: [phone]<br>Facsimile: 302.678.6540 | |
| Contact information: | Mr. Keith Edgett<br>Vice President<br>Research and Development<br>Playtex Products, Inc.<br>Telephone: [phone]<br>Facsimile: 302.678.6540 | |
| Date summary prepared: | March 15, 2007 | |
| Proprietary name of device: | Playtex Gentle Glide Plastic, Playtex Gentle Glide Plastic<br>Multipack 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.

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#### Intended Use:

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

### 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; and the dimensions of the unformed pledget pads. The shape of the final formed pledget for each absorbency is essentially identical to the predicate devices.

#### 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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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

## APR 1 3 2007

Mr. Keith Edgett Vice President Playtex Products, Inc. 804 Walker Rd. DOVER DE 19904

Re: K070745

Trade/Device Name: Playtex Gentle Glide Plastic and Playtex Gentle Glide Plastic Multipack Tampons Regulation Number: 21 CFR 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulation Number: 21 CFR 884.5470 Regulation Name: Unscented menstrual tampon Regulatory Class: II Product Code: HIL and HEB Dated: March 15, 2007 Received: March 19, 2007

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.

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Protecting and Promoting Public Health

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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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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: | K070745 |
| Device Name: | Playtex Gentle Glide Plastic and Playtex Gentle Glide Plastic<br>Multipack Tampons |
| Indications for Use: | Scented or scented deodorized menstrual tampon for the absorption<br>of menstrual fluid; unscented menstrual tampon for the absorption<br>of menstrual fluid. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the Counter Use
David A. Henderson

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

1-WA/2548871.3