510(k) Report

FDA applicant

First Quality Hygienic, Inc.

Allendale, NJ11 decisions1993–20161 recall

FDA records 11 decisions for First Quality Hygienic, Inc. (Allendale, NJ) from 1993 to 2016: 11 510(k) clearances. Most are in product codes HEB (Tampon, Menstrual, Unscented) and HIL (Tampon, Menstrual, Scented, Scented-Deodorized). Its devices cite 6 predicates, 4 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided First Quality Hygienic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2015: 12016: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — First Quality Hygienic, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like First Quality Hygienic, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HEBTampon, Menstrual, Unscented8decisions
  • HILTampon, Menstrual, Scented, Scented-Deodorized3decisions

Whose devices does it build on?

Its devices cite 6 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K151470Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and…First Quality Hygienic, Inc. · 20152cite it
  • K032173Femtex and Private Label Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 20032cite it
  • K023479Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk PackagesFirst Quality Hygienic, Inc. · 20021cites it

What has FDA decided for it lately?

  • K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull…First Quality Hygienic, Inc. · 2016
  • K151470Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and…First Quality Hygienic, Inc. · 2015
  • K051446Femtex and Private Label Opal Fresh Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005
  • K050660Femtex and Private Label Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005
  • K050067Femtex and Private Label Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2005
  • K032173Femtex and Private Label Scented Plastic Applicator TamponsFirst Quality Hygienic, Inc. · 2003
  • K031067Femtex Junior/Slender Regular Open-End TamponsFirst Quality Hygienic, Inc. · 2003
  • K023479Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and Bulk PackagesFirst Quality Hygienic, Inc. · 20021 recall

All 11 as First Quality Hygienic, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K023479Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator TamponsMar 25, 2010