Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons

The Unscented Menstrual Tampon is a device consisting of an absorbent pledget (core) surrounded by an overwrap (security veil) with a removal string, and an applicator (for some versions). It is inserted into the vagina to absorb menstrual discharge. The device is provided non-sterile and for single use only, in four absorbency levels (Light, Regular, Super, Super Plus) and three design categories: long applicator tampon, cardboard applicator tampon, and digital tampon (no applicator).

The subject device differs from the predicate (K232598) in material composition and dimensions. Key differences include: use of organic cotton pledgets (versus cotton/viscose blend in predicate), introduction of cardboard applicators (versus plastic-only in predicate), addition of a digital tampon variant without applicator, slightly different dimensional and weight specifications, different overwrap materials (organic cotton or blends versus PE+PP in predicate), and different removal string materials. The cylindrical, bullet-like tampon design and smooth-tipped applicator principle remain consistent with the predicate.

ISO 10993-1:2018 (Biological Evaluation of Medical Devices—Part 1: Evaluation and testing within a risk management process); 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). Chemical residue testing was conducted per FDA guidance on Menstrual Tampons (July 2005) to assess dioxins, furans, and pesticide/herbicide residues.

The subject device is substantially equivalent because it maintains the same intended use (vaginal insertion to absorb menstrual discharge), the same basic design principles (cylindrical tampon with applicator or digital format), and the same product classification (Class II, 21 CFR 884.5470). Although material and dimensional specifications differ, these differences do not raise different safety or effectiveness questions: biocompatibility testing on new materials (organic cotton pledgets and cardboard applicators) shows no cytotoxicity, sensitization, or irritation; chemical residue testing confirms absence of harmful dioxins, furans, and pesticides; and microbiology testing on the organic cotton version demonstrates it does not enhance Staphylococcus aureus growth or TSST-1 production. Predicate biocompatibility and chemical data were leveraged for component versions using identical materials (cotton/viscose pledgets and plastic applicators).