MODIFICATION TO PLAYTEX TAMPONS #24002

K022882 · Playtex Products, Inc. · HIL · Sep 16, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022882
• Device Name: MODIFICATION TO PLAYTEX TAMPONS #24002
• Applicant: Playtex Products, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Sep 16, 2002
• 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, unscented menstrual tampons for the absorption of menstrual fluid.

Device Story

Menstrual tampons for absorption of menstrual fluid; consists of absorbent fiber core with string; includes applicator barrel and plunger. Modified version features updated colorant composition in polyethylene resin of applicator components. Used by individuals for personal menstrual hygiene. Device functions via physical absorption of fluid. Benefits include effective management of menstrual flow.

Clinical Evidence

Bench testing only. Testing included human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritation, cytotoxicity, extraction, and TSST-1 toxin testing.

Technological Characteristics

Tampon composed of absorbent fibers and string. Applicator barrel and plunger made of polyethylene resin with modified colorant composition. Principle of operation is physical absorption of menstrual fluid. No electronic or software components.

Indications for Use

Indicated for the absorption of menstrual fluid in menstruating individuals. Available in scented, scented-deodorized, and unscented versions.

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 & Odor-absorbing Gentle Glide® (K020200–K020202)
• Playtex Non-deodorant & Deodorant Portables® (K993794)
• Playtex Non-deodorant & Deodorant Slimfits® (K961870)
• Playtex Non-deodorant & Deodorant Gentle Glide® Multipack Tampons (K830966)

Submission Summary (Full Text)

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K022882

### 510(k) SUMMARY

Playtex Products, Inc.

Name of 510(k) sponsor:

Address:

75 Commerce Drive Allendale, NJ 07401-1600 Telephone: [phone].785.8242 Facsimile:

Dr. Paul A. Siracusa Contact information: Telephone: [phone] Facsimile: 201.785.8242

August 28, 2002 Date summary prepared:

Playtex Gentle Glide®, Playtex Portables®, Playtex Gentle Proprietary name of device: Glide® Multipack, and Playtex Slimfits® tampons

Scented and Unscented Menstrual Tampons Generic/classification name:

respectively).

Product code (classification):

#### Legally Marketed (Unmodified) Devices:

Playtex Non-deodorant, Deodorant & Odor-absorbing Gentle Glide® Playtex Non-deodorant & Deodorant Portables® Playtex Non-deodorant & Deodorant Slimfits® Playtex Non-deodorant & Deodorant Gentle Glide® Multipack Tampons

Scented or scented deodorized menstrual tampons and

(HIL, 21 C.F.R. § 884.5460 and HEB, § 884.5470,

unscented menstrual tampons are Class II medical devices

K020200–K020202; K993794; K961870; K830966

#### Device Description:

Scented, Unscented menstrual tampons for the absorption of menstrual fluid.

#### Intended Use:

Playtex tampons are intended to be used as scented, 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 difference in the modified tampons from the cleared devices listed above is the composition of the colorants incorporated into the polyethylene resin used to manufacture the applicator barrel and plunger.

#### Performance Data:

Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritation, cytotoxicity, extraction, and TSST-1 toxin 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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Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a representation of a human figure, with three wavy lines forming the profile of a person's head and shoulders.

SEP 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Paul A. Siracusa, D. En. Sc. Senior Vice President, Research & Development Playtex Products, Inc. Technical Center, 75 Commerce Dr. ALLENDALE NJ 07401-1600

Re: K022882

Trade/Device Name: Playtex Non-Deodorant, Deodorant & Odor-absorbing Gentle Glide®: Non-Deodorant & Deodorant Portables®: Slimfits®: Gentle Glide® 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: 85 HIL and HEB Dated: August 29, 2002 Received: August 30, 2002

Dear Mr. Siracusa:

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 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 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:

| 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" (21 CFR Part 807.97). 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/cdrls/dsmamain.html.

Sincerely yours,

Nancy C. Brigdon

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: | K022882 |
| Device Name: | Playtex Non-deodorant, Deodorant and Odor-absorbing Gentle<br>Glide®, Playtex Non-deodorant and Deodorant Portables®, Playtex<br>Non-deodorant and Deodorant Slimfits®, and Playtex Non-<br>deodorant and Deodorant Gentle Glide® Multipack Tampons<br>(#24002) |
| Indications for Use: | Scented or scented, deodorized menstrual tampon for the<br>absorption of menstrual fluid; unscented menstrual tampon for the<br>absorption of menstrual fluid. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|------------------------------------------------------------------------------------------|
| or | |
| Over-the Counter Use | <div style="text-align: right;"> <span style="text-decoration: overline;"></span> </div> |

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K022882 |