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510(k) Data Aggregation
(23 days)
The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.
The proposed unscented menstrual tampons are cylindrical devices designed to absorb menstrual blood during a women's period. They consist 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 (except for the digital style). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip for ease of insertion. According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 7 sub-categories (Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose (digital style), Cotton + plastic tube and Viscose + cardboard tube). For applicator-style tampons, they feature a built-in applicator made of plastic or cardboard that helps the users insert the tampons into the vagina by pushing the tampon out of the applicator. The digital style tampons consist of a plain tampon designed to be inserted manually using the fingers.
The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). For Cotton + cardboard tube and Organic cotton + cardboard tube, L and SP are applicable for this application. For Cotton (digital style), Organic cotton (digital style) and Viscose (digital style), only L is applicable. For Cotton + plastic tube and Viscose + cardboard tube, all those four absorbencies are applicable for this application.
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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