# First Quality Hygienic, Inc.

- Location (FDA's records): Allendale, NJ
- FDA decisions: 11 (1993–2016): 11 510(k) clearances
- Product codes: HEB (8), HIL (3)
- Predicates its devices cite: 6 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tosama D.D.: 1 (https://510kreport.com/company/tosama-dd)
- Kimberly-Clark Corp.: 1 (https://510kreport.com/company/kimberly-clark)

## Firms that cite its devices most
- Jiangsu Yoai Technology Co., Ltd.: 1 (https://510kreport.com/company/jiangsu-yoai-technology)

## Its most-cited devices
- K151470: Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency (2015), cited by 2
- K032173: Femtex and Private Label Scented Plastic Applicator Tampons (2003), cited by 2
- K023479: Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk Packages (2002), cited by 1

## Recent decisions
- K161877: Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl (Aug 5, 2016)
- K151470: Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency (Nov 2, 2015)
- K051446: Femtex and Private Label Opal Fresh Scented Plastic Applicator Tampons (Jul 14, 2005)
- K050660: Femtex and Private Label Plastic Applicator Tampons (May 12, 2005)
- K050067: Femtex and Private Label Scented Plastic Applicator Tampons (Feb 1, 2005)
- K032173: Femtex and Private Label Scented Plastic Applicator Tampons (Sep 3, 2003)
- K031067: Femtex Junior/Slender Regular Open-End Tampons (Jul 14, 2003)
- K023479: Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk Packages (Nov 26, 2002)

Source page: https://510kreport.com/company/first-quality-hygienic