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Playtex Ultimates Tampons

by Playtex Family Products, Inc. 3 variants

510(k) K932907

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 · Traditional NumberK932907 Date7 Mar 1994ClearedStatusActive

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  • Withdrawn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)

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, 25 Sep 2026

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

Playtex Ultimates Tampons are menstrual tampons designed for the absorption of menstrual fluid. These devices are categorized as scented or scented-deodorized tampons.

This device is regulated as a Class 2 medical device under regulation number 884.5460. It has received FDA 510(k) clearance under the application number K932907.

Other devices from Playtex Family Products, Inc.

See all devices from Playtex Family Products, Inc. →

Questions

AI-generated answers, 25 Sep 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 primary purpose of Playtex Ultimates Tampons?

    These devices are designed specifically for the absorption of menstrual fluid during a woman's cycle.

  • Are these tampons scented or unscented?

    Playtex Ultimates Tampons are categorized as scented or scented-deodorized menstrual tampons.

  • What is the regulatory status of this device?

    This product is regulated as a Class 2 medical device under regulation number 884.5460 and has received FDA 510(k) clearance under application number K932907.