Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons

Unscented menstrual tampons designed to be inserted into the vagina to absorb menstrual discharge. Available in three applicator styles: long plastic applicator, cardboard applicator, and digital (no applicator). Offered in multiple absorbency levels (Light, Regular, Super, Super Plus) and material compositions (cotton, organic cotton, viscose).

Subject device differs from predicate in material composition (pledget material changed from organic cotton to cotton for long applicator variant; viscose added as new pledget option for cardboard applicator variant) and dimensional/weight specifications due to new absorbency options and size variants. All other design features—cylindrical shape, bullet-like tip, overwrap, removal string, and applicator design—remain consistent with predicate.

ISO 10993-1 (Biological Evaluation of Medical Devices); FDA guidance on Menstrual Tampons and Pads for Premarket Notification Submissions (510(k)s) regarding microbiology assessment (Staphylococcus aureus growth, TSST-1 production, vaginal microflora effects) and chemical residue assessment (July 2005).

Subject device is substantially equivalent because it uses identical raw materials to the predicate (K251033) and previously cleared devices (K232598, K252613), maintains the same indications for use, and demonstrates comparable technological characteristics. Differences in pledget/applicator combinations and new absorbency levels do not raise different questions of safety or effectiveness; biocompatibility, microbiology, and chemical residue data from predicates were successfully leveraged, and new performance testing confirmed all variants meet required standards.