# K050660: Femtex and Private Label Plastic Applicator Tampons

- Pathway: 510(k) (Traditional)
- Applicant: First Quality Hygienic, Inc.
- Decided: May 12, 2005 after 58 days
- Product code: HEB (Tampon, Menstrual, Unscented)
- Device class: 2
- Regulation: 21 CFR 884.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K896994 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023479: Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk Packages, First Quality Hygienic, Inc. (2002) Summary page 1.

## Indications for use
As a Class II Device, the menstrual tampon is defined as follows: (21CFR884.5460 and 21CFR 884 5470). Ferntex and Private I abel Plastic Applicator Tampons are a plug 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/K050660
Methodology: https://510kreport.com/methodology