Playtex Tampons #13695

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K952394 ↗

FDA Product Code

HEB

Device Class

Class II

Regulation

21 CFR Part 884.5470

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Playtex Silk Glide Odor Absorbing Flushable Cardboard Tampons #13598

  Class II

  FDA 510(k) K981760 Active Cleared 22 Jul 1998

• Playskool Sunglasses

  Class I

  FDA 510(k) K923375 Active Cleared 9 Jun 1993

• Ultimates Silk Glide Tampons

  Class II

  FDA 510(k) K950928 Active Cleared 22 Mar 1995

• Platex Oder Absorbing Gentle Glide, Slimfits and Silk Glide Tampons

  Class II

  FDA 510(k) K993794 Active Cleared 7 Feb 2000

• Playtex Tampons Gentle Glide Deordorant Tampons and Playtex/Gentle Glide Deodorant Portables Tampons

  Class II

  FDA 510(k) K964269 Active Cleared 29 Nov 1996

• Various Sunglasses

  Class I

  FDA 510(k) K923374 Active Cleared 9 Jun 1993

See all devices from Playtime Products, Inc. →

• Are Playtex Tampons #13695 reusable or designed for single-use only?

  Playtex Tampons #13695 are explicitly designed for single-use only. The product description confirms they are disposable, meaning each tampon is intended for one menstrual cycle before disposal. This aligns with standard menstrual hygiene practices to ensure hygiene and prevent contamination.

• What sizes or models are available for Playtex Tampons #13695?

  The provided data does not specify individual tampon sizes or models by name (e.g., mini, regular, super). However, the OpenFDA registration numbers list multiple variants under the product code *HEB*, indicating multiple absorbency levels (e.g., light, regular, super) are likely available. For exact sizing, refer to the manufacturer’s packaging or product documentation, as these are not detailed in the regulatory submission.

• How should Playtex Tampons #13695 be stored to maintain sterility?

  Since the tampons are sterile and single-use, they should be stored in their original, unopened packaging in a cool, dry place away from direct sunlight or moisture. Avoid exposure to extreme temperatures or contamination. The packaging is designed to preserve sterility until first use, so tampons should not be removed prematurely.

• What regulatory pathway was followed for FDA clearance of Playtex Tampons #13695?

  Playtex Tampons #13695 were cleared via the FDA 510(k) process (traditional review), with a substantial equivalence (SE) determination (decision code *SESE*). The submission was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee and classified under FDA regulation 884.5470 for menstrual tampons. The clearance (K952394) was granted on August 21, 1995, confirming compliance with Class II medical device standards.

• Are Playtex Tampons #13695 scented or unscented, and why does this matter?

  The tampons are unscented, as explicitly stated in the device description. This matters because scented products may irritate sensitive vaginal tissue or cause allergic reactions, while unscented options are generally recommended for comfort and safety during menstruation. The unscented formulation aligns with FDA’s classification for standard menstrual hygiene products.