First Quality Hygienic, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “First Quality Hygienic, Inc.” (first 1993, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 154 |
| 2016 | 1 | 28 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | 8 | 8 |
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | 3 | 3 |
Review panels
Most recent First Quality Hygienic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | HEB | 2016-08-05 | 28 |
| 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 | HEB | 2015-11-02 | 154 |
| K051446 | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS | HIL | 2005-07-14 | 42 |
| K050660 | FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | HEB | 2005-05-12 | 58 |
| K050067 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | HIL | 2005-02-01 | 20 |
| K032173 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | HIL | 2003-09-03 | 49 |
| K031067 | FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS | HEB | 2003-07-14 | 101 |
| K023479 | FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES | HEB | 2002-11-26 | 40 |
| K963034 | FEMTEX GENTLE TOUCH TAMPONS | HEB | 1996-11-01 | 88 |
| K963032 | FREE CHOICE | HEB | 1996-10-11 | 67 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-03-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- First Medical Devices Corp. (7 510(k)s)
- First Industries, Inc. (6 510(k)s)
- First Scientific Limited (5 510(k)s)
- First Medical, Inc. (4 510(k)s)
- First Ray, LLC (4 510(k)s)
- First Source, Inc. (3 510(k)s)
- First Light Diagnostics, Inc. (2 510(k)s)
- First Sense Medical, LLC (2 510(k)s)
- First Touch Disposables, Inc. (2 510(k)s)
- First Call, Inc. (1 510(k)s)
- First Check Diagnostics, LLC (1 510(k)s)
- First Glove Sdn. Bhd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under First Quality Hygienic, Inc.?
FDA lists 11 510(k) clearances under the applicant name “First Quality Hygienic, Inc.” (first 1993, latest 2016), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by First Quality Hygienic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name First Quality Hygienic, Inc. is 58 days.
Which FDA product codes appear under First Quality Hygienic, Inc.?
The most frequent FDA product codes under this applicant name are HEB (Tampon, Menstrual, Unscented, 8); HIL (Tampon, Menstrual, Scented, Scented-Deodorized, 3).
Next steps
- See all 11 First Quality Hygienic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HEB, First Quality Hygienic, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.