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Tampon, Petal Soft Plastic Applicator, Super Plus

by Tambrands Inc. 510(k)

Active United States

510(k) K896113

Overview

This device is a menstrual tampon with a petal-shaped, soft plastic applicator designed for internal insertion. It is classified as a tampon, menstrual, unscented and features a plastic applicator to facilitate placement within the vagina. The tampon is intended for menstrual fluid absorption during menstruation.

The Super Plus tampon is supplied as a single-use, non-sterile product and is intended for home use by individuals during menstruation. It is regulated under FDA 510(k) clearance (K896113) and falls under product code HEB, classified as Class II with special controls. The device is not intended for MRI use and must be stored in a cool, dry place until use.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896113 Date13 Dec 1989ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HEB
FDA applicant
Tambrands, Inc.
Device Class
Class II
Regulation
21 CFR Part 884.5470
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Petal Soft Plastic Applicator Tampon Super Plus used for?

    This tampon is designed specifically for menstrual fluid absorption during menstruation. Its petal-shaped, soft plastic applicator makes internal insertion easier, providing comfort and convenience for home use.

  • Is the Petal Soft Plastic Applicator Tampon Super Plus sterile?

    No, this tampon is supplied as a non-sterile product. It is intended for single-use and home use, so sterility is not required for its intended application.

  • How should I store the Petal Soft Plastic Applicator Tampon Super Plus?

    Store the tampon in a cool, dry place until use. Avoid exposure to moisture or extreme temperatures, as this could affect its integrity and usability.

  • Can this tampon be reused?

    No, the Petal Soft Plastic Applicator Tampon Super Plus is intended for single-use only. Reusing a tampon can pose hygiene risks and is not recommended.

  • What regulatory approval does this tampon have?

    This tampon is regulated under the FDA 510(k) clearance process, with clearance number K896113. It is classified under product code HEB as a Class II device with special controls.