Unscented menstrual three-piece applicator tampon

The unscented menstrual three-piece applicator tampon is inserted into the vagina to absorb menstrual discharge. It consists of an absorbent pledget (core) surrounded by an overwrap (security veil), a removal string, and a smooth-tipped applicator for insertion. The device is provided in four absorbency levels (Light, Regular, Super, Super Plus) and comes in four material compositions (cotton, organic cotton, viscose, and viscose+cotton).

The subject device has the same cylindrical, bullet-like tampon design and applicator shape as the predicate. Key differences include: (1) the applicator material is plastic (TPE, PP, PE) versus the predicate's non-plastic composition; (2) some tampon variants use organic cotton or viscose materials; (3) dimensional and weight specifications differ slightly; (4) primary packaging uses individual polymeric wrappers versus paper/PE/PP multi-unit packaging. All other design and material specifications remain identical to the predicate.

ISO 10993-1:2018 (biological evaluation framework), ISO 10993-5:2009/(R)2014 (in vitro cytotoxicity), ISO 10993-10:2010/(R)2014 (irritation and skin sensitization), ISO 10993-23:2021 (irritation), ISO 10993-11:2017 (systemic toxicity). Testing also followed FDA guidance on menstrual tampons and pads regarding microbiology (S. aureus, TSST-1, vaginal microflora) and chemical residues (July 2005 guidance).

The tampons (cotton, organic cotton, viscose, viscose+cotton) use identical raw materials to predicate K232598 and cleared device K251033, so their biocompatibility and microbiology data are leveraged from those submissions. The plastic applicator required new biocompatibility testing (cytotoxicity, sensitization, irritation) which demonstrated non-toxic, non-sensitizing, non-irritant results. Despite material and dimensional differences, the device retains the same indications for use, basic design (three-piece applicator system with cylindrical tampon), and functional principle as the predicate. The differences do not raise different questions of safety or effectiveness because the material changes have been biocompatibility-validated and performance testing (dimensional and ejection force) confirmed specification compliance.