# K971547: Playtex Tampons #11197, Playtex Gentle Glide, Soft Comfort and Slimfits Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Playtex Products, Inc.
- Decided: Jun 19, 1997 after 52 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Playtex Gentle Glide Tampons: named in the summary without a submission number
- (no number) Playtex Slimfits Tampons: named in the summary without a submission number
- (no number) Playtex Soft Comfort Tampons: named in the summary without a submission number

## Indications for use
Scented or scented deodorized tampons for absorption of menstrual fluid. Unscented menstrual tampons for absorption of menstrual fluid.

Source page: https://510kreport.com/device/K971547
Methodology: https://510kreport.com/methodology