# K120245: Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Playtex, Inc.
- Decided: Jun 21, 2012 after 146 days
- Product code: HIL ( Tampon, Menstrual, Scented, Scented-Deodorized)
- Device class: 2
- Regulation: 21 CFR 884.5460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K830966 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073662: Playtex Gentile Glide, Playtex Gentile Glide Multipack Tampons, Playtex Products, Inc. (2008) Summary page 1.
- K070745: Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack Tampons, Playtex Products, Inc. (2007) Summary page 1.
- K072376: Playtex Gentle Glide, Playtex Gentle Glide Multipack Tampons, Playtex Products, Inc. (2007) Summary page 1.

## Indications for use
Playtex® Gentle Glide Scented menstrual tampons are intended to be inserted into the vagina and used to absorb mnenstrual fluid. Playtex® Gentle Glide Unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

Source page: https://510kreport.com/device/K120245
Methodology: https://510kreport.com/methodology