Skip to content

Playtex Baby Powder Deodorant Tampons

by Playtex, Inc.

510(k) K843551

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843551 Date3 Dec 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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, 1 Oct 2026

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

This device is a Menstrual Tampon, Scented-Deodorized, classified under FDA regulation 884.5460. It is designed for internal vaginal use during menstruation, incorporating a deodorizing agent to reduce odor while absorbing menstrual flow. The tampons are intended for single-use and are categorized as a Class II medical device under the FDA’s product code HIL.

The Playtex Baby Powder Deodorant Tampons are supplied as single-use, non-sterile products intended for home use. They were granted FDA 510(k) clearance under the Traditional review pathway in 1984, with a decision code of SESE (Substantially Equivalent). No MRI safety or reusable specifications are noted, and the device is regulated under the Obstetrics/Gynecology specialty. Storage instructions are not specified in the data but are typically recommended at room temperature, away from direct sunlight.

Other devices from Playtex, Inc.

See all devices from Playtex, Inc. →

Questions

AI-generated answers, 1 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 Playtex Baby Powder Deodorant Tampon designed for?

    This device is a scented-deodorized menstrual tampon intended for internal vaginal use during menstruation. It combines menstrual flow absorption with a deodorizing agent to help reduce odor, making it suitable for home use by individuals managing their menstrual cycle.

  • Are these tampons sterile, and how are they supplied?

    The Playtex Baby Powder Deodorant Tampons are non-sterile and supplied as single-use units. They are packaged for individual application, ensuring hygiene for each use without requiring reprocessing.

  • What sizes or models are available for these tampons?

    This product includes multiple registration numbers (e.g., 3014833751, 3012118920, etc.), which likely correspond to different sizes or variants (e.g., mini, regular, super). The exact sizing details (e.g., absorbency levels) are not specified in the data, but the variety of registration numbers suggests multiple options for user preference.

  • Can these tampons be reused, or are they meant for one-time use?

    The tampons are explicitly designed for single-use only. Reuse is not recommended, as this could compromise hygiene, absorbency, and the effectiveness of the deodorizing agent. Each tampon is intended for one menstrual cycle application before disposal.

  • How should these tampons be stored, and what are the general handling instructions?

    While specific storage instructions are not detailed in the data, standard recommendations for non-sterile menstrual products typically advise keeping them at room temperature, away from direct sunlight, heat, or moisture. Ensure the packaging remains intact until use to maintain sterility and functionality.