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Playtex Portables Non-Deodorant & Doed. Tampons

by Playtex Family Products, Inc.

510(k) K891297

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 NumberK891297 Date8 Jun 1989ClearedStatusActive

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  • Withdrawn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, 28 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 Portables Non-deodorant & Deodorant Tampons are menstrual tampons designed for feminine hygiene use. These tampons are available in both non-deodorant and deodorant varieties, providing options for different user preferences.

The device is supplied as a single-use product and is regulated under FDA 510(k) clearance K891297 with a Class II classification. It is manufactured by Playtex Family Products, Inc. and is intended for use in obstetrics/gynecology settings. The product code is HIL and it is regulated under number 884.5460.

Other devices from Playtex Family Products, Inc.

See all devices from Playtex Family Products, Inc. →

Questions

AI-generated answers, 28 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 are Playtex Portables Tampons used for?

    Playtex Portables Tampons are designed for feminine hygiene use during menstruation. They are available in both non-deodorant and deodorant varieties to accommodate different user preferences.

  • Are Playtex Portables Tampons single-use or reusable?

    Playtex Portables Tampons are supplied as a single-use product and should not be reused. Each tampon is designed for one-time use only to ensure proper hygiene and safety.

  • What is the regulatory status of Playtex Portables Tampons?

    Playtex Portables Tampons are regulated under FDA 510(k) clearance K891297 with a Class II classification. They are manufactured by Playtex Family Products, Inc. and intended for use in obstetrics/gynecology settings.

  • What sizes and models are available for Playtex Portables Tampons?

    The device data does not specify the exact sizes or models available. However, it confirms that Playtex Portables Tampons are available in both non-deodorant and deodorant varieties to meet different user preferences.