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510(k) Data Aggregation

    K Number
    K161877
    Device Name
    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
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    2016-08-05

    (28 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.
    Device Description
    The Opal by Femtex Pull & Snap Unscented Compact Applicator Tampon is an unscented, compact menstrual tampon. It is intended for over-the-counter use for women's personal hygiene with respect to intra-vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina. The tampon itself is made of a strip of viscose rayon fibers in which a cord is inserted. A thin strip of nonwoven fiber covers the tampon, and the tampon is pressed firmly together. The applicator tubes are made of polyethylene (PE) and Polypropylene (PP) and include a barrel and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper. The tampons are marketed in Regular, Super, and Super Plus absorbencies.
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    K Number
    K151470
    Device Name
    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
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    2015-11-02

    (154 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Unscented tampon for women's personal hygiene with respect to intra vaginal absorption of menstrual or other vaginal discharge. The plastic applicator is for easing the placement of the tampon correctly into the vagina.
    Device Description
    The Opal by Femtex and Private Label Unscented Compact Applicator Tampons is an unscented, compact applicator menstrual tampon. The tampon itself is made of a strip of viscose fibers in which a cord is inserted and pressed firmly together. The viscose tampon is covered with a thin layer of non-woven fiber material which is melted on the strip. The applicator tubes are made from polyethylene (PE). The tampon with applicator is wrapped in printed polypropylene (PP) wrapping. The tampon is marketed in Light, Regular, Super, and Super Plus Absorbencies.
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    K Number
    K050660
    Device Name
    FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    2005-05-12

    (58 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Femtex and Private Label Plastic Applicator Tampons are a plug of Cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Femtex and Private Label Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. The tampons will be provided in Regular absorbency within a slender plastic applicator. Femtex and Private Label Slender Regular Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread. The material used in Femtex and Private Label Slender Regular Plastic Applicator Tampons are similar to those used in other legally marketed tampons.
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    K Number
    K050067
    Device Name
    FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    2005-02-01

    (20 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    First Quality Hygienic, Inc. Femtex and Private Label Scented Plastic Applicator tampons are a menstrual tampon that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Femtex and Private Label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided in five (5) styles/absorbencies: Light, Slender Regular, Regular, Super and Super Plus with a plastic applicator. Femtex and Private Label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance.
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    K Number
    K032173
    Device Name
    FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    2003-09-03

    (49 days)

    Product Code
    HIL
    Regulation Number
    884.5460
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Femtex and Private label Scented Plastic Applicator Tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid. As defined in 21 CFR 884.5460 and 21 CFR 884.5470, First Quality Hygienic Femtex and Other Private Label Scented Plastic Applicator Tampons, a Class II device, are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    Femtex and Private label Scented Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid, with fragrance added for aesthetic purposes. The tampons will be provided with 4 absorbencies, Junior, Regular, Super and Super Plus with a plastic applicator. Femtex and Private label Scented Plastic Applicator Tampons are made from rayon absorbent, cotton cord and cotton sewing thread, and added fragrance The material used in Femtex and Private label Scented Plastic Applicator Tampons are similar to those used in other legally marketed tampons.
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    K Number
    K031067
    Device Name
    FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    2003-07-14

    (101 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    First Quality Hygienic slender regular and Junior tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge
    Device Description
    Femtex Junior and Slender Regular Tampons are menstrual tampons used to absorb menstrual fluid. These Femtex Open-End Tampons will be provided with 2 absorbencies: Slender Regular and Junior. Femtex Open-End Junior and Slender Regular Tampons are made from rayon absorbent, cotton cord and cotton sewing thread. The material used in Femtex Open-End Junior and Slender Regular Tampons are similar to those used in other legally marketed tampons.
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    K Number
    K023479
    Device Name
    FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    2002-11-26

    (40 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    First Quality Hygienic plastic applicator tampons are a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
    Device Description
    First Ouality Hygienic Plastic Applicator Tampons are menstrual tampons used to absorb menstrual fluid. These Tampons will be marketed in four absorbencies: junior regular, super and super plus. These Tampons are made from rayon and cotton cord. The material used in these tampons are similar to those used in other legally marketed tampons in the US.
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    K Number
    K963034
    Device Name
    FEMTEX GENTLE TOUCH TAMPONS
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    1996-11-01

    (88 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Femtex Gentle Touch tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    Femtex Gentle Touch Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Gentle Touch Tampons will be provided with 3 absorbencies, regular, super and super plus. Femtex Gentle Touch Tampons are made from rayon and, cotton cord and sewing thread. The material used in Femtex Gentle Touch tampons are similar to those used in other legally marketed tampons.
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    K Number
    K963032
    Device Name
    FREE CHOICE
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    1996-10-11

    (67 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST QUALITY HYGIENIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Femtex Digital tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
    Device Description
    Femtex Digital Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Digital Tampons will be provided with 3 absorbencies, regular, super and super plus. Femtex Digital Tampons are made from rayon, polyethylene and polypropylene overwrap and cotton cord. There is no applicator
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