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Playtex Tampons and Deodorant Tampons

by Intl. Playtex, Inc.

510(k) K871197

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 NumberK871197 Date12 May 1987ClearedStatusActive

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  • Withdrawn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, classified under FDA regulation 884.5460, designed for vaginal insertion during menstruation. The product includes both standard and scented-deodorized variants, intended to absorb menstrual flow while providing odor control in the deodorant versions. The tampons are categorized as Class II medical devices under the Obstetrics/Gynecology specialty, with a focus on feminine hygiene solutions.

Playtex Tampons and Deodorant Tampons are single-use, non-sterile disposable products supplied in various sizes and applicator types (e.g., HIL reference codes). They are intended for home use and require no special storage conditions beyond keeping them in a cool, dry place. The device holds FDA 510(k) clearance (K871197) under a Traditional review pathway, with a decision date of May 12, 1987, and is regulated under the Obstetrics/Gynecology advisory committee. No MRI safety or reusable components are indicated in the specifications.

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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 are Playtex Deodorant Tampons designed for?

    Playtex Deodorant Tampons are designed for vaginal insertion during menstruation to absorb menstrual flow while providing odor control. The scented-deodorized variant is specifically formulated to address both absorption and fragrance concerns, making them suitable for home use during periods.

  • Are Playtex Tampons single-use or reusable?

    Playtex Tampons are single-use, disposable products. Each tampon is intended for one-time use only, ensuring hygiene and safety. After use, they should be discarded, and a new tampon should be inserted as needed.

  • What sizes and applicator types are available?

    Playtex Tampons come in various sizes and are supplied with different applicator types, including HIL reference codes. These variations allow users to select the most comfortable and effective option based on their menstrual flow and personal preference.

  • Do Playtex Tampons require special storage conditions?

    No, Playtex Tampons do not require special storage conditions beyond keeping them in a cool, dry place. This ensures the product remains effective and safe for use when needed.

  • What regulatory pathway was followed for FDA clearance?

    Playtex Tampons received FDA clearance under the Traditional review pathway, classified as substantially equivalent to a predicate device. The clearance (K871197) was granted on May 12, 1987, under the Obstetrics/Gynecology specialty category, ensuring compliance with FDA regulations for menstrual hygiene products.