Playtex Ultimates Tampons

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K934083 ↗

FDA Product Code

HIL

Device Class

Class II

Regulation

21 CFR Part 884.5460

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Playtex Tampons #04994 Unscented & Scented

  Class II

  FDA 510(k) K940821 Active Cleared 25 Mar 1994

• Playtex Flushable Tampons Regular, Super, Super +

  Class II

  FDA 510(k) K924279 Active Cleared 21 May 1993

• Playtex Non-Deodorant and Deodorant Tampons

  Class II

  FDA 510(k) K884737 Active Cleared 10 Jan 1989

• Playtex Non-Deodorant Tampons, Playtex Deodorant Tampons

  Class II

  FDA 510(k) K935276 Active Cleared 7 Mar 1994

• Playtex Ultimates Tampons/Unscented and Scented

  Class II

  FDA 510(k) K936189 Active Cleared 7 Mar 1994

• Scented or Scented Deodorized, Unscented Tampons

  Class II

  FDA 510(k) K897012 Active Cleared 22 Dec 1989

See all devices from Playtex Family Products, Inc. →

• What is the Playtex Ultimates Tampon used for?

  The Playtex Ultimates Tampon is a menstrual tampon designed for use during menstruation to absorb menstrual flow. It is scented and scented-deodorized, intended for vaginal application as a single-use product.

• Is the Playtex Ultimates Tampon sterile or non-sterile, and is it reusable?

  The Playtex Ultimates Tampon is supplied as a non-sterile product and is intended for single-use only. It is not designed to be cleaned, sterilized, or reused after initial use due to hygiene and safety considerations for vaginal devices.

• How is the Playtex Ultimates Tampon supplied and what are its key characteristics?

  The device is supplied as a scented, scented-deodorized menstrual tampon for vaginal use. It is a single-use, non-sterile product made for managing menstrual flow during menstruation, with no indication of multiple sizes or models in the provided data.