Unscented Tampon

The Unscented Tampon is a traditional menstrual tampon intended for vaginal insertion to absorb menstrual or other vaginal discharge. It consists of a pledget made from 100% organic cotton or 100% viscose, a removal string (organic cotton or polyester-cotton blend), and a cardboard applicator. The device is provided non-sterile in four absorbency levels (light, regular, super, and super plus) for single use only.

The proposed device shares the same cylindrical, bullet-like design with a smooth rounded applicator tip as the predicate. Both use the same product code (HEB), regulatory classification (Class II), and absorbency ranges (≤6g to 12-15g). The primary differences are minor variations in component dimensions (pledget diameter, applicator length), applicator material (cardboard versus polyethylene/polypropylene in predicate), and finishing agents on the removal string and pledget, though core materials remain compatible.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (vaginal irritation), ISO 10993-11:2017 (acute systemic toxicity), and 21 CFR 801.430 (absorbency/Syngyna testing). The submission also references FDA guidance documents on menstrual tampons (July 27, 2005) and the ISO 10993-1 biological evaluation framework (September 4, 2020).

The subject device has identical indications for use, design principles, and material composition to the predicate device K231341. Biocompatibility testing demonstrated non-cytotoxic, non-irritating, non-sensitizing properties equivalent to the predicate. Microbiology testing confirmed the device does not enhance Staphylococcus aureus growth, increase TSST-1 production, or alter normal vaginal microflora—addressing the primary safety concern for tampons. Performance testing showed the device meets all dimensional and functional specifications. The minor dimensional and finishing agent differences do not raise new safety or effectiveness questions.