Super Petal Soft Plastic Applicator Tampax Tampons

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

510(k) Number

K861910 ↗

FDA Product Code

HEB

FDA applicant

Tambrands, Inc.

Device Class

Class II

Regulation

21 CFR Part 884.5470

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Unscented Menstrual Tampon, Plastic Applicator

  Class II

  FDA 510(k) K962476 Active Cleared 13 Aug 1996

• Tampax Deodorant Tampon, Slender Regular

  Class II

  FDA 510(k) K872260 Active Cleared 10 Jul 1987

• Modified Regular Deodorant Maxithins Pads

  Class II

  FDA 510(k) K862678 Active Cleared 15 Aug 1986

• Tampax Ultrafit Panty Shields - Mofification

  Class I

  FDA 510(k) K891474 Active Cleared 7 Jun 1989

• Slender Regular Tampons

  Class II

  FDA 510(k) K864650 Active Cleared 4 Mar 1987

• Maxithins Body-Shaped Panty Shields

  Class I

  FDA 510(k) K842951 Active Cleared 23 Aug 1984

See all devices from Tambrands Inc. →

• What is the Super Petal Soft Plastic Applicator Tampax Tampons used for?

  These tampons are designed for menstrual use, featuring a soft plastic applicator with petal-like features to ensure comfortable insertion and use during menstruation. They are intended for use in obstetrics/gynecology settings.

• How are the Super Petal Soft Plastic Applicator Tampax Tampons supplied?

  The tampons are supplied as a single-use product, meaning they are designed for one-time use only and should not be reused. They are available in various sizes as indicated by the multiple registration numbers associated with this clearance.

• What is the regulatory status of the Super Petal Soft Plastic Applicator Tampax Tampons?

  This product is a Class II medical device regulated under FDA 510(k) clearance with product code HEB. It has been determined to be substantially equivalent to other marketed devices of the same type.

• Are the Super Petal Soft Plastic Applicator Tampax Tampons scented?

  No, these tampons are unscented. They are classified as a tampon, menstrual, unscented product, making them suitable for individuals who prefer or require unscented menstrual products.