Playtex Non-Deodorant/Deodorant Tampons
by Playtex Family Products, Inc.
510(k) K912002
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK912002 | Date12 Aug 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HIL
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5460
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Playtex Non-Deodorant/Deodorant Tampons are menstrual tampons designed for internal use. These devices are classified as scented, scented-deodorized, or unscented products intended to absorb menstrual fluid.
This device is regulated under FDA 510(k) clearance as a class 2 medical device. It is categorized under the Obstetrics and Gynecology medical specialty and is identified by regulation number 884.5460.
Other devices from Playtex Family Products, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the primary purpose of Playtex Non-Deodorant/Deodorant Tampons?
These tampons are designed for internal use to effectively absorb menstrual fluid during a woman's cycle.
What varieties of this tampon are available?
The product line includes three distinct options to suit user preference: scented, scented-deodorized, and unscented versions.
How are these tampons regulated?
Playtex Non-Deodorant/Deodorant Tampons are classified as class 2 medical devices under the Obstetrics and Gynecology specialty, regulated under number 884.5460 and cleared via the FDA 510(k) process.