Search Results
Found 6 results
510(k) Data Aggregation
K Number
K191666Device Name
Unscented W long plastic and cardboard applicator tampons
Manufacturer
ONTEX BVBA
Date Cleared
2019-12-20
(182 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ONTEX BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unscented W long plastic and cardboard applicator Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.
Device Description
The Unscented W long plastic and cardboard applicator Tampons are unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of 100% viscose with polymeric overwrap. The applicator is a full size applicator provided in polyethylene or cardboard. The absorbent pledget has a W wadding design and is available in light, regular, super and super plus absorbencies.
Ask a Question
K Number
K162746Device Name
Ontex and other proprietary names
Manufacturer
ONTEX BVBA
Date Cleared
2017-03-03
(154 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ONTEX BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The W long plastic applicator Tampons are inserted into the vagina to absorb menstrual discharge.
Device Description
The W long plastic applicator Tampons are conventional unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of organic cotton. The applicator is in polyethylene and of full size (long). The pledget has a W wadding design. The Tampons are available in regular and super absorbencies.
Ask a Question
K Number
K142786Device Name
Ontex Unscented Tampons with Colored Plastic Applicators
Manufacturer
ONTEX BVBA
Date Cleared
2015-06-23
(270 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ONTEX BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ontex Unscented Tampons with Colored Plastic Applicators are inserted into the vagina to absorb menstrual discharge.
Device Description
Tampons included in this submission are conventional unscented menstrual tampons consisting of an absorbent pledget (viscose material in a W-shape wadding form), polyester/cotton withdrawal cord, and a polymeric overwrap. The tampon component of this submission is identical to that cleared in the predicate submission (K122603).
Tampons included in this submission are placed in the vagina using a polyethylene applicator. The applicator is available in two sizes: full size (long) or compact size. The full size applicator is ready for use. The compact size consists of an inner and outer tube that requires the inner tube to be retracted prior to use. Applicators included in this submission are provided in different colors including green, yellow, lilac, orange and pink.
Ask a Question
K Number
K132595Device Name
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
Manufacturer
ONTEX BVBA
Date Cleared
2014-04-23
(247 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ONTEX BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Roll wadding plastic Applicator Compact size Unscented Tampons are inserted into the vagina to absorb menstrual discharge.
Device Description
The Roll wadding plastic Applicator Compact size Unscented Tampon is a menstrual tampon. These tampons are unscented tampons it means without any perfume. These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is made from polyester and cotton. These tampons have an applicator. The applicator is made from plastic (polyethylene). . The applicator is in a compact size meaning that the inner tube and the outer tube are slided into each other telescopically so the inner tube needs to be retracted before usage. These tampons have a Roll wadding form. In a roll tampon, the fleece band is folded and then rolled (like a Swiss roll) before being radially pressed. The Roll wadding plastic Applicator Compact size Unscented Tampon is available in 3 absorbencies: regular, super plus absorbency (regular (6-9g), super (9-12g), and super plus (12-15g)).
Ask a Question
K Number
K132208Device Name
ONTEX AND OTHERS PROPRIETARY NAMES
Manufacturer
ONTEX BVBA
Date Cleared
2014-04-10
(268 days)
Product Code
HIL, DEV
Regulation Number
884.5460Why did this record match?
Applicant Name (Manufacturer) :
ONTEX BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scented Digital and Plastic Applicator Tampons are inserted into the vagina to absorb menstrual discharge.
Device Description
The Scented Tampons are:
1) Scented Digital
2) Scented Plastic Applicator (full size (long) and compact)
They are scented versions because of the presence of a fragrance.
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (<6g), regular (6-9g), super (9-12g), and super plus (12-15g).
These tampons are made from viscose material and polymeric overwrap. The withdrawal cord is in polyester and cotton. Applicators are in polyethylene.
Roll-tampon: sheet of absorbent material is rolled and pressed. W-tampon: sheet of absorbent material is folded and pressed from two sides simultaneously.
Long applicator: inner tube and outer tube are ready to be used immediately. Compact applicator: inner tube and outer tube are slided into each other telescopically. The inner tube needs to be retracted before usage.
Except for the perfume, the materials used in these tampons are similar to materials of legally marketed tampons.
Ask a Question
K Number
K122603Device Name
ONTEX AND OTHER PROPRIETARY NAMES
Manufacturer
ONTEX BVBA
Date Cleared
2012-12-19
(114 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
ONTEX BVBA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ontex Unscented Digital and Plastic and Cardboard Applicator Tampons, Available in light, regular, super, and super plus absorbency are inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Device Description
The Ontex Tampons are:
- 1) Unscented Digital
- Unscented Plastic Applicator 2)
- 3) Unscented Cardboard Applicator
Both the Applicator and Digital Tampons are inserted into the vagina to absorb menstrual or other vaginal discharge.
These tampons, both the digital types and the applicator types will be provided with 4 absorbencies: light (<6g), regular (6-9g), super, (9-12g), and super plus (12-15g)
These Tampons are made from viscose and/or cotton cellulosic material and polymeric overwrap and cotton or cotton polyester cord. Applicators are either polyethylene or polypropylene.
The materials used in these tampons are similar to those used in other legally marketed tampons..
Ask a Question
Page 1 of 1