PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS

K072376 · Playtex Products, Inc. · HIL · Dec 12, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K072376
• Device Name: PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
• Applicant: Playtex Products, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

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

Device Story

Playtex Gentle Glide Tampons are menstrual hygiene products designed for the absorption of menstrual fluid. The device consists of an absorbent pledget made of rayon cross-pads and an applicator barrel and plunger made of polyethylene resin. The device is operated by the user for self-insertion. The primary function is the mechanical absorption of fluid. The device features a wavy band flared finger grip and a rolled end plunger design. It is intended for over-the-counter use. The device provides a hygienic method for managing menstruation, potentially improving user comfort and convenience during use.

Clinical Evidence

Clinical evidence includes a double-blind, randomized, comparative in-use evaluation of tampon products assessing overall safety and effect on vaginal microflora. Bench testing included cytotoxicity, acute systemic toxicity, vaginal irritation, dermal irritation, allergic contact sensitization, microbial agar diffusion, and TSST-1 testing. Absorbency was verified to be in compliance with 21 C.F.R. § 801.430(e)(1) for Ultra absorbency.

Technological Characteristics

Materials: Rayon cross-pads (pledget), polyethylene resin (applicator barrel/plunger). Design: Wavy band flared finger grip, rolled end plunger. Function: Mechanical absorption of menstrual fluid. Compliance: 21 C.F.R. § 801.430(e)(1) for Ultra absorbency. Biocompatibility: Tested for cytotoxicity, systemic toxicity, irritation, and sensitization.

Indications for Use

Indicated for the absorption of menstrual fluid in menstruating individuals. Available in scented, scented deodorized, and unscented versions. 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 Playtex Non-deodorant & Deodorant Gentle Glide Multipack Tampons (K070745)

Submission Summary (Full Text)

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DEC 1 2 2007

| Name of 510(k) sponsor: | Playtex Products, Inc. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Playtex Products, Inc.<br>804 Walker Rd.<br>Dover, DE 19904<br>Telephone:<br>302.678.6880<br>Facsimile:<br>302.678.6540 |
| Contact information: | Mr. Keith Edgett<br>Vice President<br>Research and Development<br>Playtex Products, Inc.<br>Telephone:<br>302.678.6880<br>Facsimile:<br>302.678.6540 |
| Date summary prepared: | July 24, 2007 |
| Proprietary name of device: | Playtex Gentle Glide, Playtex Gentle Glide Multipack<br>Tampons (Ultra Absorbency) |
| 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). |

510(k) SUMMARY

# Legally Marketed (Unmodified) Devices:

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

#### K070745

### 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 deodorized, unscented menstrual tampons for the absorption of menstrual fluid.

#### Technological Characteristics:

The new ultra absorbency tampon has the same technological characteristics as the cleared tampon. The fiber; string; colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger; deodorizing scent; and materials in contact with the vaginal wall are the same or have the same mode of action. The only differences between the Playtex Gentle Glide Tampons and the predicate devices listed above are: the absorbency level, wavy band -- flared finger grip design, rolled end plunger design, applicator dimensions, the dimensions of the rayon cross-pads used to form the pledget, and the dimensions of the final formed pledget.

#### Biocompatibility and 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), and a clinical study [double-blind, randomized, comparative in-use evaluation of tampon products for overall safety and effect on the vaginal micro flora] testing indicate that the modified device meets all device input requirements.

#### Syngyna Absorbency Results

The new scented and unscented tampons are in compliance with the requirements for Ultra absorbency as set forth in 21 C.F.R. § 801.430(e)(1), "User Labeling for Menstrual Tampons."

#### Conclusions:

The modified Playtex ultra absorbency 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines suggesting movement or connection.

#### Public Health Service

DEC 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Keith Edgett Vice President Research and Development Playtex Products, Inc. 804 Walker Road DOVER DE 19904

Re: K072376

Trade Name: Playtex Gentle Glide and Playtex Gentle Glide Multipack Tampons Regulation Number: 21 CFR §884.5460 Regulation Name: Scented menstrual tampon Regulatory Class: II Product Code: HIL and HEB Dated: October 31, 2007 Received: November 2, 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 (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.

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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/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 STATEMENT

# Indications for Use

KO72376 510(k) Number (if known):

| Device Name: | Playtex Gentle Glide and Playtex Gentle Glide Multipack |
|--------------|---------------------------------------------------------|
| | Tampons |

Indications for Use: Scented or scented deodorized menstrual tampon for the absorption of menstrual fluid; unscented menstrual tampon for the absorption of menstrual fluid.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| Division of Reproductive, Abdominal and<br>Radiological Devices |
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510(k) Number ________________________________________________________________________________________________________________________________________________________________

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