Playtex Tampons
510(k) K861738
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861738 | Date22 Jul 1986 | 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- Withdrawn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, 1 Oct 2026
A tampon is a menstrual device designed to absorb menstrual flow. This device is classified as a scented, deodorized tampon for menstrual use.
It is supplied as a single-use device and is regulated under FDA 510(k) clearance (K861738) as a Class II medical device. The device is intended for use in the obstetrics and gynecology setting and is not MRI safety tested or specified as reusable.
Other devices from Playtex, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the intended use of PLAYTEX TAMPONS?
PLAYTEX TAMPONS are designed to absorb menstrual flow and are intended for use in the obstetrics and gynecology setting as a menstrual device.
Are PLAYTEX TAMPONS supplied as single-use or reusable devices?
PLAYTEX TAMPONS are supplied as single-use devices and are not intended for reuse, as specified in the device description and regulatory documentation.
What regulatory pathway was used for PLAYTEX TAMPONS and what is the associated clearance number?
PLAYTEX TAMPONS were cleared through the FDA 510(k) process under traditional clearance, with the associated K-number K861738, indicating substantial equivalence to a predicate device.