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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
Shandong Intco Hygiene Products Co., Ltd.
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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