PLAYTEX DEODORANT TAMPONS, MODEL 34802

• K Number: K020200
• Device Name: PLAYTEX DEODORANT TAMPONS, MODEL 34802
• Manufacturer: PLAYTEX PRODUCTS, INC.
• Date Cleared: 2002-03-13 ( 50 days)
• Product Code: HIL
• Regulation Number: 884.5460

Intended Use

Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.

Device Description

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

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a menstrual tampon and does not mention any AI or ML technology. The performance studies are related to biological and chemical safety, not algorithmic performance.

Therapeutic

No.
The device is a menstrual tampon for fluid absorption, which is not considered a therapeutic function. Therapeutic devices are typically used for treating, curing, mitigating, or preventing a disease.

Diagnostic

No
The device is a menstrual tampon, intended for absorption of menstrual fluid, not for diagnosing any condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "menstrual tampon," which is a physical, hardware medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "for the absorption of menstrual fluid." This is a physical function within the body, not a diagnostic test performed on a sample in vitro (outside the body).
• Device Description: The description confirms it's a menstrual tampon, designed for absorption.
• Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
• Performance Studies: The performance studies listed focus on safety and physical properties (irritation, toxicity, absorption-related testing like TSST-1), not diagnostic accuracy or performance metrics like sensitivity or specificity.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.

Product codes (comma separated list FDA assigned to the subject device)

85 HIL and HEB

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Nonclinical testing referenced for the determination of substantial equivalence includes: Human sensitization, dermal irritation, acute oral toxicity, subacute vaginal irritations, agar diffusion and TSST-1 toxin testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 884.5460 Scented or scented deodorized menstrual tampon.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

9. 510(k) SUMMAR Y

MAR 1 3 2002

SUMMARY OF SAFETY AND EFFECTIVENESS A.

1.	COMPANY NAME	-	Playtex Products Inc.
	ADDRESS	-	75 Commerce Drive
Allendale, New Jersey 07401
	TELEPHONE	-	201-785-8000
	CONTACT PERSON	-	M. Rosengarten
Director, Regulatory, Safety &
International Development
	DATE OF SUMMARY	-	January 18, 2002
2.	DEVICE NAME	-	Playtex Tampons
	CLASSIFICATION NAME	-	Scented, Deodorized Menstrual
Tampons

• The new Playtex tampons are substantially equivalent to the following 3. tampons that have been previously cleared:
  • a. Playtex Deodorant Gentle Glide® in Regular, Super and Super Plus absorbencies
  • b. Playtex Deodorant Portables® in Regular and Super absorbencies
  • c. Playtex Deodorant Gentle Glide Multipack in Regular and Super absorbencies
  • d. Deodorant Slimfits® in Regular absorbency
• The device description is: Scented, deodorized menstrual tampons for the 4. absorption of menstrual fluid.
• Playtex tampons are intended to be used as scented, deodorized menstrual న. tampons for the absorption of menstrual fluid.
• The new tampon has the same technological characteristics as the 6. The fiber, string and materials in contact with the predicate device. vaginal wall are the same or have the same mode of action.
• Nonclinical testing referenced for the determination of substantial B. 1. equivalence includes:

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

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

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three heads or faces, with wavy lines below the heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2002

Mr. Mark E. Rosengarten Director, Regulatory, Safety & International Development Playtex Products, Inc. Technical Center 75 Commerce Dr. ALLENDALE NJ 07401-1600 Re: K020200 Trade/Device Name: Playtex Deodorant Tampons

Model 34802 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: January 18, 2002 Received: January 22, 2002

Dear Mr. Rosengarten:

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.

2

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, Jour responsible in Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

3

STATEMENT OF INDICATIONS OF USE PAGE

Page 1 of 1

510(k) Number (if known): KOマO200

Device Name: Playtex Deodorant Gentle Glide®, Playtex Deodorant Portables®, Playtex Deodorant Gentle Glide® Multipack and Playtex Deodorant Slimfits® Tampons Model #34802

Indications For Use:

Scented or scented, deodorized menstrual tampon for the absorption of menstrual fluid.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

David H. Beynon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020200