First Quality Hygienic, Inc.

Medical device manufacturer in Mcelhattan, PA.

11510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon…HEB · Special 08/05/2016SE
K151470Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency…HEB · Abbreviated 11/02/2015SE
K051446Femtex and Private Label Opal Fresh Scented Plastic Applicator TamponsHIL · Traditional 07/14/2005SE
K050660Femtex and Private Label Plastic Applicator TamponsHEB · Traditional 05/12/2005SE
K050067Femtex and Private Label Scented Plastic Applicator TamponsHIL · Traditional 02/01/2005SE
K032173Femtex and Private Label Scented Plastic Applicator TamponsHIL · Traditional 09/03/2003SE
K031067Femtex Junior/Slender Regular Open-End TamponsHEB · Traditional 07/14/2003SE
K023479Femtex Tampons and Other Private Label Plastic Applicator Tampons; Consumer Packages and…HEB · Traditional 11/26/2002SE
K963034Femtex Gentle Touch TamponsHEB · Traditional 11/01/1996SE
K963032Free ChoiceHEB · Traditional 10/11/1996SE
K920238Private Labels and FemtexHEB · Traditional 08/02/1993SE

Recalls

RecallProductInitiated
Z-2466-2010 Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator TamponsLife Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus… 03/25/2010Terminated