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Playtex Ultimates Tampons, Unscented/Scented

by Playtex Family Products, Inc.

510(k) K914438

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 NumberK914438 Date2 Jan 1992ClearedStatusActive

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  • Withdrawn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 Ultimates Unscented/Scented 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, 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.

The Playtex Ultimates Tampons are menstrual hygiene products designed for internal use during menstruation. These tampons are classified as Class II medical devices and are intended to absorb menstrual flow, providing comfort and protection for individuals during their menstrual cycle. Available in both unscented and scented variants, they cater to varying preferences for odor control and sensory experience.

These tampons are supplied as single-use, non-sterile products and are regulated under FDA 510(k) clearance (K914438) as substantially equivalent to a predicate device. They are intended for home use and must be inserted into the vagina manually. The product is available in multiple absorbency levels, as indicated by the registration numbers, and is stored in multipacks for convenience. No MRI safety information is specified, and the devices are not intended for reuse.

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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 Ultimates Tampons used for?

    Playtex Ultimates Tampons are used for absorbing menstrual flow, providing comfort and protection during menstruation.

  • Are Playtex Ultimates Tampons sterile?

    No, Playtex Ultimates Tampons are supplied as non-sterile, single-use products.

  • Can Playtex Ultimates Tampons be reused?

    No, Playtex Ultimates Tampons are intended for single use and are not designed for reuse.

  • How are Playtex Ultimates Tampons supplied?

    Playtex Ultimates Tampons are supplied in multipacks for convenience, with multiple absorbency levels available.