Search Results
Found 9 results
510(k) Data Aggregation
K Number
K161877Device 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
884.5470Why 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
K151470Device 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
884.5470Why 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
K050660Device 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
884.5470Why 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
K050067Device 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
884.5460Why 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
K032173Device 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
884.5460Why 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
K031067Device 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
884.5470Why 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
K023479Device 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
884.5470Why 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
K963034Device Name
FEMTEX GENTLE TOUCH TAMPONS
Manufacturer
FIRST QUALITY HYGIENIC, INC.
Date Cleared
1996-11-01
(88 days)
Product Code
HEB
Regulation Number
884.5470Why 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
K963032Device Name
FREE CHOICE
Manufacturer
FIRST QUALITY HYGIENIC, INC.
Date Cleared
1996-10-11
(67 days)
Product Code
HEB
Regulation Number
884.5470Why 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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