Did You Know... Tampon Education

Did You Know… Tampon Education

1. Playtex Sport Tampons are Regulated by the FDA

Our tampons are regulated by the U.S. Food and Drug Administration (FDA) through its Center for Devices and Radiological Health (CDRH). This agency ensures that medical devices like Playtex Sport are safe, effective, and high quality.

2. Tampons are Classified as Class II Medical Devices

Tampons are class II medical devices. Before Playtex Sport tampons can be sold in the U.S., it must go through a rigorous process called 510(k) clearance with the FDA. This is not just a formality. It’s a detailed safety and effectiveness review.

We must prove that our tampon is just as safe and effective as another product already on the market. To do that, we submit a full package of scientific data and testing results, including:

- - Biocompatibility: to ensure materials and products are safe for the body
  - Absorbency: to confirm product performance and proper labeling
  - Durability: to ensure the product holds together during use
  - Microbial safety: to confirm that the product doesn’t support germ growth or release toxins

The FDA reviews all of this before giving us the green light. This process helps protect your health and ensures our products meet strict regulatory standards.

💬 Did you know? Other class II devices include contact lenses and condoms.

3. Manufacturing and FDA Oversight

Playtex Sport manufacturing facilities follow strict quality and safety standards. The FDA can inspect them at any time to ensure we comply with:

- - FDA’s Quality System Regulations: covering everything from design to production to packaging.
  - International standards like ISO 13485:2016: a global benchmark for medical device quality management.

We also monitor our products after they’re on the market to ensure they continue to meet safety, quality, and performance expectations.

4. Toxic Shock Syndrome (TSS) Labeling

As required by the FDA, all tampon packaging includes a TSS warning. This includes: