SABA Tampons

SABA® Tampons are unscented menstrual tampons intended for vaginal insertion to absorb menstrual or other vaginal discharge. They are available in two versions (with or without an applicator) in three absorbency levels: regular (6-9g), super (9-12g), and super plus (12-15g). The device is non-sterile, single-use, and made primarily of viscose pledget, non-woven polyethylene/polyester cover, and polyester/viscose removal cord.

The subject device uses a 100% viscose pledget (same as predicate) with similar cylindrical shape and bullet-like tip applicator design. Minor dimensional variations exist in pledget length, diameter, and removal string length across absorbency levels, though these remain within acceptable ranges. The subject device differs from the predicate by introducing a light absorbency option not present in the predicate, and by using a bicomponent non-woven cover rather than the predicate's polyethylene/polyethylene terephthalate blend.

ISO 10993-1 (biocompatibility framework), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitivity), ISO 10993-23:2021 (vaginal irritation), ISO 10993-11:2017 (acute systemic toxicity). FDA guidance documents for menstrual tampons and pads (July 27, 2005) were applied for performance testing (dimensions, absorbency, removal string strength, tampon integrity, chemical residues) and microbiology testing.

The device shares identical indications for use, product code (HEB), regulatory classification (Class II), and fundamental design as the predicate. Biocompatibility and microbiology testing demonstrate equivalent safety profiles—the subject device does not enhance S. aureus growth, increase TSST-1 production, or alter normal vaginal microflora. All technological differences (material substitutions, dimensional variations, additional light absorbency option) do not raise different safety or effectiveness questions because they remain within acceptable performance parameters and comply with the same testing standards as the predicate.