Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons
510(k) K072376
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072376 | Date12 Dec 2007 | 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- Withdrawn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, 23 Sep 2026
This device is a tampon, menstrual, scented, scented-deodorized, as defined in the device name and specifications. It is a menstrual tampon product designed for use during menstruation.
The device is supplied as a multipack of tampons and is intended for single-use. It is regulated under FDA 510(k) clearance (K072376) and classified as a Class II medical device with product code HIL, falling under the Obstetrics/Gynecology medical specialty.
Other devices from Playtex Products, Inc.
Questions
AI-generated answers, 23 Sep 2026
What is the Playtex Gentle Glide tampon used for?
The Playtex Gentle Glide tampon is a menstrual product designed to absorb menstrual flow during menstruation, as specified in its device name and intended use.
Is the Playtex Gentle Glide tampon scented or unscented?
The Playtex Gentle Glide tampon is scented and scented-deodorized, as indicated in the device name and specifications provided in the regulatory data.
How is the Playtex Gentle Glide tampon supplied and is it reusable?
The device is supplied as a multipack of tampons and is intended for single-use only, meaning each tampon is designed to be used once and then discarded.
What regulatory pathway was used for the Playtex Gentle Glide tampon?
The Playtex Gentle Glide tampon received FDA 510(k) clearance under submission number K072376, which determined it to be substantially equivalent to a legally marketed predicate device.
What is the product code and device class for the Playtex Gentle Glide tampon?
The device is classified under product code HIL and is a Class II medical device, as indicated in the openfda data and regulatory classification fields.