Playtex Modified Fiber Tampons
510(k) K811660
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811660 | Date16 Jul 1981 | 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- Withdrawn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, 25 Sep 2026
Playtex Modified Fiber Tampons are menstrual tampons designed for internal use during menstruation. These tampons are made with modified fiber materials and are available in various sizes to accommodate different flow needs.
The device is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code HIL. It is classified as a Class II medical device for obstetrics/gynecology use and is manufactured by Playtex, Inc.
Other devices from Playtex, Inc.
Questions
AI-generated answers, 25 Sep 2026
What are Playtex Modified Fiber Tampons used for?
Playtex Modified Fiber Tampons are designed for internal use during menstruation. They are made with modified fiber materials and come in various sizes to accommodate different flow needs.
Are Playtex Modified Fiber Tampons single-use or reusable?
Playtex Modified Fiber Tampons are supplied as a single-use product. They are designed for one-time use during menstruation and should not be reused.
What sizes and models of Playtex Modified Fiber Tampons are available?
Playtex Modified Fiber Tampons are available in various sizes to accommodate different flow needs. The specific sizes and models may vary, but they are all designed for internal menstrual use.
How are Playtex Modified Fiber Tampons regulated?
Playtex Modified Fiber Tampons are regulated under FDA 510(k) clearance with product code HIL. They are classified as a Class II medical device for obstetrics/gynecology use.