Platex Gentle Glide, Silk Glide, Slimfits, Soft Comfort, and Portables Tampons

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K982383 ↗

FDA Product Code

HIL

Device Class

Class II

Regulation

21 CFR Part 884.5460

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Playtex Deodorant Tampons, Model 34702

  Class II

  FDA 510(k) K020202 Active Cleared 12 Mar 2002

• Playtex Ultimates Silk Glide Tampons #23094

  Class II

  FDA 510(k) K944155 Active Cleared 9 Feb 1995

• Playtex Ultimates Silk Glide Tampons #22994

  Class II

  FDA 510(k) K944154 Active Cleared 9 Feb 1995

• Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons

  Class II

  FDA 510(k) K070745 Active Cleared 13 Apr 2007

• Playtex Deodorant Tampons, Model 34802

  Class II

  FDA 510(k) K020200 Active Cleared 13 Mar 2002

• Playtex Slimfit Tampons

  Class II

  FDA 510(k) K961870 Active Cleared 19 Jun 1996

See all devices from Playtex Products, Inc. →

• What are the Playtex Gentle Glide tampons designed for?

  The Playtex Gentle Glide, Silk Glide, SlimFits, Soft Comfort, and Portables tampons are designed exclusively for vaginal insertion during menstruation to absorb menstrual flow. They are intended for home use only and are not meant for clinical or medical procedures. Their design prioritizes comfort and ease of use for individuals managing their menstrual cycle.

• Are these tampons single-use or reusable?

  These tampons are strictly single-use items. Each tampon is intended for one-time use only and should not be reused. This ensures hygiene and safety, as reusing a tampon can increase the risk of irritation or infection. The product packaging is designed to maintain sterility until first use.

• What variants of these tampons are available?

  The Playtex tampons come in two variants: scented and scented-deodorized. The scented variant provides a mild fragrance, while the scented-deodorized variant combines fragrance with odor control. Both are designed to enhance comfort and convenience during menstruation. The specific models include Gentle Glide, Silk Glide, SlimFits, Soft Comfort, and Portables, each offering slight variations in absorbency or design.

• How should these tampons be stored?

  These tampons should be stored in a cool, dry place, away from direct sunlight and moisture. The original packaging should remain intact until use to preserve sterility. Avoid storing them in humid environments, such as bathrooms, as this can compromise the tampons' integrity and effectiveness. Proper storage ensures the tampons remain safe and ready for use when needed.

• What regulatory approvals do these tampons have?

  The Playtex Gentle Glide, Silk Glide, SlimFits, Soft Comfort, and Portables tampons are authorized under FDA 510(k) clearance with the clearance number K982383. This classification confirms they meet FDA standards for safety and effectiveness as menstrual tampons. The device falls under product code HIL and is categorized under Class II medical devices with special controls, specifically for Obstetrics/Gynecology use.