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Playtex Sport Fresh Balance Tampons

by Playtex Manufacturing, Inc.

510(k) K132819

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK132819 Date9 Oct 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Playtex (Scented and Unscented) Sport Fresh Balance Tampons
510(k) Number
FDA Product Code
HIL
Device Class
Class II
Regulation
21 CFR Part 884.5460
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Playtex Sport Fresh Balance Tampons are menstrual tampons available in scented and unscented options. They are designed with 360-degree protection and Flex-Fit technology to fit and adjust to the body with movement.

These tampons are supplied in various absorbencies from Regular to Ultra and are available in multiple pack sizes. The device is FDA 510(k) cleared with product code HIL and is classified as a Class II medical device for obstetrics/gynecology use.

Other devices from Playtex Manufacturing Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of Playtex Sport Fresh Balance Tampons?

    Playtex Sport Fresh Balance Tampons are menstrual hygiene products designed with 360-degree protection and Flex-Fit technology to fit and adjust to the body with movement, available in both scented and unscented options.

  • What absorbencies and pack sizes are available for Playtex Sport Fresh Balance Tampons?

    These tampons are supplied in various absorbencies ranging from Regular to Ultra and are available in multiple pack sizes to accommodate different flow needs and usage preferences.

  • What is the regulatory classification of Playtex Sport Fresh Balance Tampons?

    The device is FDA 510(k) cleared with product code HIL and is classified as a Class II medical device for obstetrics/gynecology use, as determined by the FDA's review process.

  • How does the Flex-Fit technology in Playtex Sport Fresh Balance Tampons work?

    Flex-Fit technology allows the tampon to fit and adjust to the body with movement, providing 360-degree protection and comfort during various activities, which is particularly beneficial for active individuals.