COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS are unscented menstrual tampons made of organic cotton with an absorbent core, security veil, and withdrawal string. They are inserted into the vagina to absorb menstrual fluid and are available in four absorbency levels: light, regular, super, and super plus. Each tampon features a compact polyethylene applicator with telescoping inner and outer tubes.

The key difference from the predicate device is the addition of a polyethylene compact applicator to facilitate insertion. The tampon component itself (absorbent pledget, organic cotton cover, and withdrawal cord) is identical to the non-applicator predicate device. The applicator uses a telescopic design where the inner tube must be retracted before use.

ISO 10993-1 (biocompatibility evaluation framework); ISO 10993-5:2009 (cytotoxicity); ISO 10993-10:2010 and 2021 (vaginal irritation and delayed hypersensitivity); ISO 10993-11:2017 (acute systemic toxicity); ISO 10993-23:2021 (vaginal irritation for applicator); 21 CFR 801.430(f)(2) (absorbency testing per Syngyna method); and FDA Guidance for Industry on Menstrual Tampons and Pads (July 27, 2005).

The tampon component is identical to the predicate device K211775 (COHITECH ORGANIC COTTON NON-APPLICATOR COTTONLOCK TAMPONS), so its non-clinical data is leveraged directly. The polyethylene applicator addition is supported by biocompatibility testing and expulsion force performance testing, both demonstrating safety and functionality. The device therefore maintains substantial equivalence to the predicate in indications for use, materials, performance characteristics, and safety profile.