# K032173: Femtex and Private Label Scented Plastic Applicator Tampons

- Pathway: 510(k) (Traditional)
- Applicant: First Quality Hygienic, Inc.
- Decided: Sep 3, 2003 after 49 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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) Femtex and Private label Plastic Applicator tampons: named in the summary without a submission number

## Most influential descendants
- K051446: Femtex and Private Label Opal Fresh Scented Plastic Applicator Tampons (2005), 0 descendants of its own
- K050067: Femtex and Private Label Scented Plastic Applicator Tampons (2005), 0 descendants of its own

## Indications for use
As defined in 21 CFR 884.5460 and 21 CFR 884.5470, First Quality Hygienic Femtex and Other Private Label Scented Plastic Applicator Tampons, a Class II device, are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.

Source page: https://510kreport.com/device/K032173
Methodology: https://510kreport.com/methodology