PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS

K120245 · Playtex, Inc. · HIL · Jun 21, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120245
• Device Name: PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
• Applicant: Playtex, Inc.
• Product Code: HIL · Obstetrics/Gynecology
• Decision Date: Jun 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5460
• Device Class: Class 2

Indications for Use

Playtex scented or scented deodorized menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid. Playtex unscented menstrual tampons are inserted into the vagina and used to absorb menstrual fluid.

Device Story

Playtex Gentle Glide tampons are menstrual hygiene products designed for vaginal insertion to absorb menstrual fluid. The device consists of a pledget and a plastic applicator (barrel and plunger). Modifications from predicate devices include updated colorants in the polyethylene applicator resin, a new fragrance, and a revised pledget design. The device is intended for over-the-counter use by consumers. Performance is verified through Syngyna testing to ensure compliance with established absorbency ranges (Slender Light through Ultra). Safety is established through biocompatibility, microbiological, and clinical sensitization/irritation testing.

Clinical Evidence

Clinical evidence included Human Repeat Insult Patch Test (sensitization) and Human Vaginal Irritation (safety-in-use) studies. Preclinical testing included cytotoxicity, rabbit vaginal irritation, acute systemic toxicity, zone of inhibition (microflora), and Toxic Shock Syndrome testing. Performance testing (Syngyna) confirmed adherence to 21 CFR §801.430(f)(2) absorbency ranges.

Technological Characteristics

Menstrual tampon with pledget and polyethylene resin applicator. Modifications include new colorants in applicator, new fragrance, and new pledget design. Operates via physical absorption of menstrual fluid. Complies with 21 CFR §801.430(f)(2) for absorbency.

Indications for Use

Indicated for use by individuals requiring absorption of menstrual fluid. Available in various absorbency ranges from <6g to 18g.

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® Gentle Glide and Playtex® Gentle Glide Multipack Tampons (K073662)
• Playtex® Gentle Glide Plastic and Playtex® Gentle Glide Plastic Multipack Tampons (K070745)
• Playtex® Non-deodorant Gentle Glide (unscented), Playtex Deodorant Gentle Glide (Scented) and Playtex Non-deodorant and Deodorant Multipack Tampons (K072376)

Submission Summary (Full Text)

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JUN 2 1 2012

K120245

| 510(k) Summary | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of 510(k) Sponsor | Playtex Products, LLC<br>6 Research Drive<br>Shelton, CT 06484 |
| Contact Information | Pushpa Rao, Ph.D., D.A.B.T., R.A.C.<br>Senior Manager, Product Safety/North American Regulatory Affairs<br>Research & Development<br>Playtex Products, LLC<br>75 Commerce Drive<br>Allendale, NJ 07401<br>Telephone: [phone]<br>Facsimile: 201-785-8202 |
| Summary prepared on | January 25, 2012 |
| Pre-Market Notification # | |
| Reason for Submission | Changes to the applicator colorant, fragrance and pledget design<br>compared to predicate tampons. Pre-clinical and clinical testing<br>confirmed that these changes did not affect the safety of the modified<br>tampon. These changes were not expected to affect efficacy, and this<br>was verified by performance testing. The results of these tests are<br>included in this 510(k) pre-market notification. |
| Name of Device | |
| Trade Name | Playtex® Gentle Glide Scented Tampons<br>Playtex® Gentle Glide Unscented Tampons |
| Common Name | Menstrual Tampon, Scented and Unscented |
| Classification Name | Tampon, Menstrual Scented and Unscented |
| Classification Code | HIL, HEB |
| Predicate Devices | Playtex® Gentle Glide and Playtex® Gentle Glide Multipack Tampons<br>(K073662)<br><br>Playtex® Gentle Glide Plastic and Playtex® Gentle Glide Plastic<br>Multipack Tampons (K070745)<br><br>Playtex® Non-deodorant Gentle Glide (unscented), Playtex Deodorant<br>Gentle Glide (Scented) and Playtex Non-deodorant and Deodorant<br>Multipack Tampons (K072376) |
| Device Description | Scented or scented deodorized, unscented menstrual tampons for the<br>absorption of menstrual fluid. |
| Intended Use | Playtex scented or scented deodorized menstrual tampons are intended |
| | unscented menstrual tampons are inserted into the vagina and used to<br>absorb menstrual fluid. |
| Technological<br>Characteristics | The modified tampons have the same technological characteristics as the<br>predicate devices (K070745, K072376 and K073662). The fiber and<br>materials in contact with the vaginal wall are the same or have the same<br>mode of action. The only differences in the modified tampons from the<br>predicate tampons are: (1) the composition of the colorants incorporated<br>into the polyethylene resin used to manufacture the applicator (barrel<br>and plunger); (2) a new fragrance; (3) a new pledget design. |
| Biocompatibility Tests | Biocompatibility and microbiological studies of the modified tampons<br>were conducted in accordance with the FDA guidance and applicable<br>standards. The results demonstrate that the modified Playtex Gentle<br>Glide tampons are safe and effective for their intended use and are<br>substantially equivalent to legally marketed predicate tampons. The<br>testing included: |
| | Preclinical:<br>Cytotoxicity<br>Vaginal Irritation in Rabbits<br>Acute Systemic Toxicity<br>Zone of Inhibition (Vaginal Microflora)<br>Toxic Shock Syndrome Test<br>In vitro Vaginal Irritation |
| | Clinical<br>Human Repeat Insult Patch Test (Sensitization)<br>Human Vaginal Irritation (Safety In Use) |
| Performance Testing | Syngyna testing was conducted in accordance to 21 CFR §801.430(f)(2)<br>to verify that the modified tampons met absorbency ranges as specified<br>in the regulation. |
| | ● Absorbs menstrual flow < 6 grams (Slender Light)<br>● Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)<br>● Absorbs menstrual flow 9-12 grams (Super)<br>● Absorbs menstrual flow 12-15 grams (Super Plus)<br>● Absorbs menstrual flow 15-18 grams (Ultra) |
| | The tampons are labeled in accordance to these absorbency ranges. |
| Conclusion | The results of the preclinical and clinical testing indicate that the<br>modified tampons are safe and effective for their intended use and when<br>considered in conjunction with the performance testing results are |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

#### JUN 2 1 2012

Pushpa Rao, Ph.D., D.A.B.T. R.A.C. Senior Manager, Product Safety/North American Regulatory Affairs Playtex, Inc. 75 Commerce Drive ALLENDALE NJ 07401

Re: K120245

Trade/Device Name: Playtex® Gentle Glide Scented & Unscented Tampons Regulation Number: 21 CFR§ 884.5460 Regulation Name: Scented or scented deodorized menstrual tampon Regulatory Class: II Product Code: HIL, HEB Dated: June 11, 2012 Received: June 12, 2012

Dear Dr. Rao:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Benjamin R. Tucker

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

# 510(k) Number (if known):

# Device Name:

Playtex® Gentle Glide Scented Tampons

Playtex® Gentle Glide Unscented Tampons

#### Indications For Use:

Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Absorbency Ranges:

Absorbs menstrual flow < 6 grams (Slender Light)

Absorbs menstrual flow 6-9 grams (Slender Regular, Regular)

Absorbs menstrual flow 9-12 grams (Super)

Absorbs menstrual flow 12-15 grams (Super Plus)

Absorbs menstrual flow 15-18 grams (Ultra)

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use _X_<br>(21 CFR 801 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K120245 |