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510(k) Data Aggregation
K Number
K242105Device Name
SABA Tampons
Manufacturer
Essity Higiene Y Salud Mexico. S.A. DE C.V.
Date Cleared
2025-04-01
(257 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
The SABA® Tampons are traditional unscented menstrual tampons. The SABA® Tampons are available either with a single use applicator or as a digital tampon (without an applicator). Except for the inclusion of the applicator, both types of tampons are made of the same materials. Each device consists of a tampon, including a 100% viscose pledget ("absorbent core") surrounded by a non-woven fabric cover blend of polyethylene and polyester, a removal cord of 67% polyester/33% viscose, and an applicator (only for the applicator tampon). The applicator is made of an inner tube of high-density polypropylene and an external tube of low-density polyethylene, both with 5% pink pigment. The applicator has a smooth, rounded tip to ease insertion.
Both the applicator and applicator free SABA® Tampons are provided in three absorbencies of regular (6-9g), super (9-12g), and super plus (12-15g). Each device is individually wrapped in a metallized printed bi-oriented polypropylene lamination and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.
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K Number
K241064Device Name
Unscented Tampon
Manufacturer
Shandong Intco Hygiene Products Co., Ltd.
Date Cleared
2025-01-10
(267 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unscented Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
The Unscented Tampons are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The Unscented Tampons are provided with a cardboard applicator tampon. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget , a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and a cardboard applicator . The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The Unscented Tampons are provided in 4 absorbencies: light (less than or equal to 6g), regular (6~9g), super (9~12g) and super plus (12~15g). Each device is individually wrapped. It is provided non-sterile and for single use only.
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K Number
K240708Device Name
Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
Manufacturer
Suzhou Borage Medical Technology Co., Ltd.
Date Cleared
2024-05-10
(56 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Organic Cotton Tampon and Organic Cotton PESCV cord Tampon are intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are traditional unscented menstrual tampons. They share the same design and raw materials except the material of the removal strings. Each of them are available in two configurations (i.e., digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. Both of Organic Cotton Tampon and Organic Cotton PESCVcord Tampon are provided in 4 absorbency: light (≤6g), regular (6-9g), super (9-12g) and super plus (12-15g). Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.
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K Number
K232060Device Name
TOSAMA Reusable Applicator
Manufacturer
Tosama, d.o.o.
Date Cleared
2024-04-12
(276 days)
Product Code
HEB, HIL
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TOSAMA Reusable Applicator is intended to be used to insert a digital (no applicator) menstrual tampon into the vagina.
Device Description
The TOSAMA Reusable Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold in three different packaging configurations: Applicator with prepackaged tampons (regular, super and super plus absorbency versions) and Applicator with loose tampons of super and regular absorbency. The device is comprised of a tampon holder and pusher made of thermoplastic elastomer and a lipstick-style cap to protect the applicator, which is made of polystyrene. The tampon holder and pusher are connected at the hinged base of the holder, which opens to load a tampon and closes to allow the pusher to eject a tampon. The holder and pusher are designed to stay connected and not separate during use, storage, or cleaning. The TOSAMA Reusable Applicator requires the user to load the applicator with a legally marketed menstrual tampon. The use-life of the subject TOSAMA Reusable Applicator is 2 years. The device requires the user to clean (holder and pusher) and disinfect (lipstick cap) before initial use, before long term storage and at the end of the menstrual cycle, as well as to clean the device after each use. The applicator is available in one size for all sizes of tampon absorbencies (Light, Regular, Super and Super Plus) and accommodates a maximal tampon diameter of 15 mm. The holder inner diameter is 8.2 + 0.25/- 0.10 mm, pusher length is 83.7 ±0.5 mm and total length and diameter of the applicator (without the lipstick cap) is 70.8 ± 1.0 mm and 19.6 ±0.05 mm respectively.
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K Number
K232598Device Name
Unscented Menstrual Tampon
Manufacturer
Unibeauty (Hubei) Technology Co.,Ltd.
Date Cleared
2023-12-15
(109 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Unscented Menstrual Tampon is inserted into the vagina to absorb menstrual discharge.
Device Description
The Unscented Menstrual Tampons are menstrual tampons used to absorb menstrual fluid. These tampons are provided in 4 absorbencies, light (≤ 6 grams absorbency), regular (6-9 grams), super (9-12 grams) and super plus (12-15 grams). These tampons include a pledget made from viscose and cotton as well as a polyester and polypropylene overwrap. The removal string is made of polypropylene yarn and cotton yarn. The applicator tubes are made of low density polyethylene (LDPE). The assembled tampon with applicator is wrapped in a printed polyethylene wrapper.
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K Number
K223883Device Name
Daye Tampon
Manufacturer
Annes Daye Ltd
Date Cleared
2023-08-18
(234 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Daye Tampons are indicated for insertion into the vagina to absorb menstrual discharge.
Device Description
The Daye Tampons are unscented menstrual tampons consisting of an absorbent cotton pledget and a plastic (polyethylene) full-size applicator. The tampon pledget is made entirely of organic cotton, is fashioned with a W'wadding design and protective sleeve/overwrap. A withdrawal cord, made from mercerised organic cotton, is attached to the pledget. The Daye Tampons are available in regular (6-9 grams) and super (9-12 grams) absorbencies. The Daye Tampons and applicator are gamma irradiated in the finalpackaging. The Daye Tampons and applicators are repackaged together.
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K Number
K231341Device Name
Organic cotton tampon, Viscose tampon
Manufacturer
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd.
Date Cleared
2023-08-14
(97 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
The organic cotton tampon and viscose tampon are traditional unscented menstrual tampons. Except for the raw materials, they share the same design. The organic cotton tampon and viscose tampon, both have two types i.e., digital tampon and applicator tampon. The tampon applicator is available in two colors - milky and pink. Each device consists of a tampon, including an absorbent 100% organic cotton or 100% viscose pledget ("absorbent core") surrounded by polyethylene and polyethylene terephthalate overwrap ("security veil"), a 100% organic cotton or polyester and cotton removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The applicator is made of polyethylene and polypropylene. The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. Both, organic cotton tampon and viscose tampon, are provided in 4 absorbencies: light (≤6g), regular (6~9g), super (9~12g) and super plus (12~15g). Each device is individually wrapped in a polyethylene/nonwoven laminated film or cellophane film and packaged in sealed multi-unit containers for retail sale. It is provided non-sterile and for single use only.
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K Number
K230419Device Name
Sequel Tampon with Plastic Applicator
Manufacturer
Tampro Inc
Date Cleared
2023-08-03
(168 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sequel tampon with plastic applicator is an unscented tampon provided with a plastic applicator used for easing the placement of the tampon correctly into the vagina. The Sequel tampon is inserted into the vagina and used to absorb menstrual or other vaginal discharge.
Device Description
The Sequel Tampon with Plastic applicator are menstrual tampons used to absorb menstrual fluid. These Tampons are available in Regular absorbency (6-9 grams). These Tampons are made from rayon fibers and a polyethylene/polyester overwrap in which a cotton/polyester withdrawal cord is inserted. The applicator is a compact style polyethylene applicator with cylindrical barrel with a plunger. The assembled tampon with applicator is wrapped in a printed polypropylene wrapper. The tampon and applicator are single-use and non-sterile.
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K Number
K223749Device Name
U by Kotex® Click® Unscented Menstrual Tampons
Manufacturer
Kimberly-Clark Corporation
Date Cleared
2023-01-06
(23 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
U by Kotex® Click® Unscented Menstrual Tampon is an unscented tampon inserted into the vagina to absorb menstrual fluid.
Device Description
The U by Kotex® Click® Unscented Menstrual Tampon is a conventional unscented menstrual tampon consisting of an absorbent pledget and a telescoping three-piece plastic applicator. The device will be manufactured in Regular, Super, and Super Plus absorbencies. The absorbent pledget consists of an absorbent core of radially wound rayon ribbon compressed into a grooved cylinder with a rounded, bullet-like tip, a non-woven overwrap cover, and a rayon-polyester blend withdrawal string. The three-piece applicator consists of an outer insertion tube (barrel) with a textured grip and formed with a closed, rounded tip in a petal-like design, a clear middle telescopic tube (telescope), and an elongated insertion tube (plunger). Each tampon is individually sealed in a plastic film primary wrapper and then packaged in sealed multi-unit containers for retail sale.
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K Number
K222046Device Name
Unscented Menstrual Tampon
Manufacturer
Suzhou Borage Medical Technology Co., Ltd.
Date Cleared
2022-09-30
(81 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Product Code :
HEB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The unscented menstrual tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
The proposed device is a traditional unscented menstrual tampon, and it has two types (i.e. digital tampon and applicator tampon). Each device consists of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by overwap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon is of the traditional cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion. The proposed device is provided in 4 absorbencies: light (≤6g), regular (6~9g), super (9~12g) and super plus (12~15g). Each device is individually wrapped and packaged in sealed multi-unit containers for retail sale. And it is provided non-sterile and for single use only.
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