PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS

• K Number: K120245
• Device Name: PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
• Manufacturer: PLAYTEX, INC.
• Date Cleared: 2012-06-21 ( 146 days)
• Product Code: HIL , HEB
• Regulation Number: 884.5460
• Type: Traditional
• Panel: OB
• Reference & Predicate Devices: K073662 , K070745 , K072376

Intended 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

Device Description

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

AI/ML Overview

The Playtex® Gentle Glide Scented and Unscented Tampons (K120245) have specific acceptance criteria related to absorbency, which were verified through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Absorbency Range per 21 CFR §801.430(f)(2))	Reported Device Performance (Absorbency Grams)
Slender Light

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).