# K023479: Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk Packages

- Pathway: 510(k) (Traditional)
- Applicant: First Quality Hygienic, Inc.
- Decided: Nov 26, 2002 after 40 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896994 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K896994: Kotex Security Tampons (Several Type), Kimberly-Clark Corp. (1989) Summary page 2.

## Most influential descendants
- K050660: Femtex and Private Label Plastic Applicator Tampons (2005), 0 descendants of its own

## Recalls of this device
- Mar 25, 2010 · Not classified · Z-2466-2010: Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus Unscented Plastic Applicator Tampons.

## Indications for use
First Quality Hygienic plastic applicator tampons 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/K023479
Methodology: https://510kreport.com/methodology