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Playtex Flushable Tampons Regular, Super, Super +

by Playtex Family Products, Inc.

510(k) K924279

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 NumberK924279 Date21 May 1993ClearedStatusActive

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  • Withdrawn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.

The Playtex Flushable Tampons Regular, Super, and Super + are classified as menstrual tampons, designed for internal menstrual absorption. These disposable, single-use devices are inserted into the vagina to absorb menstrual flow, providing protection during menstruation. The product line includes varying absorbency levels to accommodate different flow intensities, ensuring comfort and reliability for users.

These tampons are supplied in sterile packaging for single-use and are intended for home use. They are classified as Class II medical devices under FDA regulations and have received 510(k) clearance through the Obstetrics/Gynecology advisory committee. The devices are not intended for MRI use and must be disposed of properly after use, as they are not designed for flushing. Each tampon is individually packaged for hygiene and convenience.

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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 Flushable Tampons Regular, Super, and Super+ used for?

    These tampons are designed for internal menstrual absorption during menstruation. They are inserted into the vagina to absorb menstrual flow, providing protection and comfort for users with different flow intensities. The varying absorbency levels (Regular, Super, Super+) cater to light, moderate, and heavy menstrual flow, ensuring reliable protection throughout the menstrual cycle.

  • Are Playtex Flushable Tampons supplied sterile and for single-use only?

    Yes, these tampons are supplied in sterile packaging, ensuring hygiene and safety for single-use only. Each tampon is individually wrapped to maintain sterility and prevent contamination before use. This design aligns with medical-grade standards for menstrual hygiene products.

  • Can Playtex Flushable Tampons be reused or flushed?

    No, these tampons are intended for single-use only and must not be reused or flushed down toilets. They are not designed for flushing and improper disposal can cause plumbing issues. After use, they should be disposed of in a sealed trash receptacle following local waste disposal guidelines.

  • What absorbency levels are available, and how do they differ?

    Playtex Flushable Tampons come in three absorbency levels: Regular (for light flow), Super (for moderate flow), and Super+ (for heavy flow). The absorbency levels are determined by the material and construction of the tampon, allowing users to select the appropriate size based on their menstrual flow intensity for optimal comfort and protection.

  • Are these tampons suitable for MRI use?

    No, these tampons are not intended for use during MRI scans. The materials used in their construction may interfere with MRI imaging or pose a risk to the user. If an MRI is required, users should remove the tampon beforehand and consult their healthcare provider for guidance on alternative protection methods.