PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS

K993794 · Playtime Products, Inc. · HEB · Feb 7, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993794
• Device Name: PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
• Applicant: Playtime Products, Inc.
• Product Code: HEB · Obstetrics/Gynecology
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5470
• Device Class: Class 2

Indications for Use

Unscented menstrual tampons for absorption of menstrual fluid.

Device Story

Playtex tampons are unscented menstrual devices designed for the absorption of menstrual fluid. The device consists of absorbent fibers and a string, with materials selected for contact with the vaginal wall. The device functions through physical absorption of fluid. It is intended for over-the-counter use by individuals during menstruation.

Clinical Evidence

No clinical data. Nonclinical testing included human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritation, agar diffusion, Dioxin analysis, and TSST-1 toxin testing.

Technological Characteristics

Unscented menstrual tampon consisting of absorbent fibers and string. Materials in contact with the vaginal wall are identical to predicate devices. Operates via physical absorption. No electronic or software components.

Indications for Use

Indicated for use as unscented menstrual tampons for the absorption of menstrual fluid.

Regulatory Classification

Identification

An unscented 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. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.

Predicate Devices

• Playtex Gentle Glide® (K993794)
• Silk Glide® (K993794)
• Slimfits® (K993794)

Submission Summary (Full Text)

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7 2000 FEB

Kaa3794

#### ರು 510(k) SUMMARY

#### SUMMARY OF SAFETY AND EFFECTIVENESS A.

| 1. | COMPANY NAME | - | Playtex Products Inc. |
|----|---------------------|---|------------------------------------------------------------------|
| | ADDRESS | - | 75 Commerce Drive<br>Allendale, New Jersey 07401 |
| | TELEPHONE | - | 201-785-8000 |
| | CONTACT PERSON | - | M. Rosengarten<br>Director of Regulatory & Biomedical<br>Affairs |
| | DATE OF SUMMARY | - | November 5, 1999 |
| 2. | DEVICE NAME | - | Playtex Tampons |
| | CLASSIFICATION NAME | - | Unscented Menstrual Tampons |

- 3. The new Playtex tampons are substantially equivalent to previously cleared Playtex Gentle Glide® and Silk Glide®, Regular, Super and Super Plus tampons, and Slimfits® Regular and Super tampons.
- 4. The device description is: Unscented menstrual tampons for the absorption of menstrual fluid.
- રું Playtex tampons are intended to be used as unscented menstrual tampons for the absorption of menstrual fluid.
- 6. The new tampon has the same technological characteristics as the predicate device. The fiber, string and materials in contact with the vaginal wall are the same or have the same mode of action.
- B. 1. Nonclinical testing referenced for the determination of substantial equivalence includes:

Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion, Dioxin analysis and TSST-1 toxin testing.

- 2. Based on the review of the data referenced in this "510(k) Summary," the Playtex tampons are substantially equivalent to the predicate device in terms of safety and effectiveness.

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# Kga3794

### CONFIDENTIAL

#### 10. FOR TREATMENT AS REQUEST CONFIDENTIAL COMMERCIAL INFORMATION UNDER 21 C.F.R. 807.95 (b) AND REQUEST FOR CONTINUING CONFIDENTIALITY UNDER 807.95(C)(3).

I, Dr. Irwin Butensky, Sr. Vice President, R&D, Playtex Products, Inc., ("Playtex") certify as follows:

- Playtex deems its intent to market Playtex Tampons #30999 to be confidential ( i) commercial information.
- To the best of Playtex's knowledge, neither I nor anyone else has disclosed ( ii) Playtex's intent to market the subject device through advertising or any other manner, to scientists, market analysts, exporters, or other individuals or companies, except to employees of or paid consultants to Playtex or to individuals in an advertising firm pursuant to commercial arrangements with appropriate safeguards for secrecy.
- (iii) Playtex shall notify the FDA immediately if its intent to market the device is disclosed to anyone, except to its employees, or to its paid consultants or individuals such as in an advertising or law firm, pursuant to commercial arrangements with appropriate safeguards for secrecy.
- Playtex has taken precautions to protect the confidentiality of its intent to market ( iv) Playtex tampons #30999.
- (v) I understand that submission of false information to the U.S. Government is prohibited by 18 U.S.C. 1001 and 21 U.S.C. 331(g).

Respectfully submitted.

Irwin Butensky

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17 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Mark Rosengarten Director Regulatory & Biomedical Affairs Research & Development Playtex Products, Inc. Technical Center 75 Commerce Drive Allendale, NJ 07401-1600

Re: K993794

Playtex Odor Absorbing Gentle Glide® Slimfits® and Silk Glide® Tampons Dated: November 5, 1999 Received: November 9, 1999 Regulatory Class: II 21 CFR §884.5470/Procode: 85 HEB

Dear Mr. Rosengarten:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 vour 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS OF USE PAGE

Page 1 of 1

510(k) Number (if known): K 993794

Device Name: __ Playtex Odor Absorbing Gentle Glide . Slimfits® and Silk Glide® Tampons Indications For Use:

Unscented menstrual tampons for absorption of menstrual fluid.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use. √

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 2794 510(k) Number.