Search Results
Found 3 results
510(k) Data Aggregation
K Number
K191431Device Name
Interlude Rolled Tampons in Plastic Applicator
Manufacturer
ALBAAD fem
Date Cleared
2019-10-07
(131 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ALBAAD fem
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Interlude rolled tampons in plastic applicator are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Device Description
Interlude rolled tampons in plastic applicator are menstrual tampons used to absorb menstrual fluid. These tampons will be provided with 3 absorbencies - Regular, Super and Super Plus. These Tampons are rolled and made from organic cotton and polymeric overwrap in which a cotton cord is inserted. The applicator tubes are made of plant-based polyethylene and include a cylindrical barrel with finger grip and a one-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.
Ask a Question
K Number
K181911Device Name
Interlude 100% Cotton Tampon
Manufacturer
ALBAAD fem
Date Cleared
2018-11-02
(108 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ALBAAD fem
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Interlude 100% Cotton Tampons are inserted into the vagina and used to absorb menstrual or other discharge.
Device Description
Interlude 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are made from cotton absorbing fibers and cotton overwrap to which a cotton cord is sewed with a cotton sewing thread. The applicator tubes are made of cardboard and include a cylindrical barrel and a plunger. The assembled tampon with applicator is wrapped in a printed paper, polyethylene (PE), or polypropylene (PP) wrapper. The subject devices are provided with the following three absorbencies: Light: <6 grams Regular: 6-9 grams Super: 9-12 grams
Ask a Question
K Number
K173225Device Name
Interlude and private label Unscented 3-piece compact applicator tampon
Manufacturer
ALBAAD fem
Date Cleared
2018-06-15
(255 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ALBAAD fem
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Interlude and private label Unscented 3-piece applicator tampons are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Device Description
Interlude and private label Unscented 3-piece compact applicator tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 2 absorbencies, regular and super. These tampons are made from rayon fibers and polymeric overwrap. The withdrawal cord is made of cotton and polyester. The applicator tubes are made of polyethylene (PE) and include a cylindrical barrel with a finger grip and a two-piece plunger. The assembled tampon with applicator is wrapped in a printed PE wrapper.
Ask a Question
Page 1 of 1