Company ยท US
First Quality Hygienic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2016. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 5, 2016 | K161877 | Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and First Quality Hygienic, Inc. | HEB |
| Nov 2, 2015 | K151470 | Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label First Quality Hygienic, Inc. | HEB |
| Jul 14, 2005 | K051446 | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS First Quality Hygienic, Inc. | HIL |
| May 12, 2005 | K050660 | FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS First Quality Hygienic, Inc. | HEB |
| Feb 1, 2005 | K050067 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS First Quality Hygienic, Inc. | HIL |
| Sep 3, 2003 | K032173 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS First Quality Hygienic, Inc. | HIL |
| Jul 14, 2003 | K031067 | FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS First Quality Hygienic, Inc. | HEB |
| Nov 26, 2002 | K023479 | FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES First Quality Hygienic, Inc. | HEB |
| Nov 1, 1996 | K963034 | FEMTEX GENTLE TOUCH TAMPONS First Quality Hygienic, Inc. | HEB |
| Oct 11, 1996 | K963032 | FREE CHOICE First Quality Hygienic, Inc. | HEB |
| Aug 2, 1993 | K920238 | PRIVATE LABELS AND FEMTEX First Quality Hygienic, Inc. | HEB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2010 | First Quality Hygienic Inc Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons Terminated |
HEB | K023479 |