# K971979: Playtex Tampons #14897/Playtex Gentle Glide,Silk Glide, Slimfits,Soft Comfort and Portables Tampons

- Pathway: 510(k) (Traditional)
- Applicant: Playtex Products, Inc.
- Decided: Sep 26, 1997 after 120 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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 Silk 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
- (no number) Playtex Portables® Tampons: named in the summary without a submission number

## Indications for use
Scented, Scented Deodorant and Unscented menstrual tampons for absorption of menstrual fluid: Part 21 C. F. R., Section 884.5460 and Section 884.5470 respectively.

Source page: https://510kreport.com/device/K971979
Methodology: https://510kreport.com/methodology