Skip to content

Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons

by Playtex Products, Inc.

510(k) K072376

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 NumberK072376 Date12 Dec 2007ClearedStatusActive

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  • Withdrawn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, 23 Sep 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 tampon, menstrual, scented, scented-deodorized, as defined in the device name and specifications. It is a menstrual tampon product designed for use during menstruation.

The device is supplied as a multipack of tampons and is intended for single-use. It is regulated under FDA 510(k) clearance (K072376) and classified as a Class II medical device with product code HIL, falling under the Obstetrics/Gynecology medical specialty.

Other devices from Playtex Products, Inc.

See all devices from Playtex Products, Inc. →

Questions

AI-generated answers, 23 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 is the Playtex Gentle Glide tampon used for?

    The Playtex Gentle Glide tampon is a menstrual product designed to absorb menstrual flow during menstruation, as specified in its device name and intended use.

  • Is the Playtex Gentle Glide tampon scented or unscented?

    The Playtex Gentle Glide tampon is scented and scented-deodorized, as indicated in the device name and specifications provided in the regulatory data.

  • How is the Playtex Gentle Glide tampon supplied and is it reusable?

    The device is supplied as a multipack of tampons and is intended for single-use only, meaning each tampon is designed to be used once and then discarded.

  • What regulatory pathway was used for the Playtex Gentle Glide tampon?

    The Playtex Gentle Glide tampon received FDA 510(k) clearance under submission number K072376, which determined it to be substantially equivalent to a legally marketed predicate device.

  • What is the product code and device class for the Playtex Gentle Glide tampon?

    The device is classified under product code HIL and is a Class II medical device, as indicated in the openfda data and regulatory classification fields.