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Playtex Modified Fiber Tampons

by Playtex, Inc.

510(k) K811660

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 NumberK811660 Date16 Jul 1981ClearedStatusActive

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  • Withdrawn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, 25 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 Modified Fiber Tampons are menstrual tampons designed for internal use during menstruation. These tampons are made with modified fiber materials and are available in various sizes to accommodate different flow needs.

The device is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code HIL. It is classified as a Class II medical device for obstetrics/gynecology use and is manufactured by Playtex, Inc.

Other devices from Playtex, Inc.

See all devices from Playtex, Inc. →

Questions

AI-generated answers, 25 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 Modified Fiber Tampons used for?

    Playtex Modified Fiber Tampons are designed for internal use during menstruation. They are made with modified fiber materials and come in various sizes to accommodate different flow needs.

  • Are Playtex Modified Fiber Tampons single-use or reusable?

    Playtex Modified Fiber Tampons are supplied as a single-use product. They are designed for one-time use during menstruation and should not be reused.

  • What sizes and models of Playtex Modified Fiber Tampons are available?

    Playtex Modified Fiber Tampons are available in various sizes to accommodate different flow needs. The specific sizes and models may vary, but they are all designed for internal menstrual use.

  • How are Playtex Modified Fiber Tampons regulated?

    Playtex Modified Fiber Tampons are regulated under FDA 510(k) clearance with product code HIL. They are classified as a Class II medical device for obstetrics/gynecology use.