GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

GentleCath Air for Men, GentleCath Glide Intermittent Catheter, and GentleCath Air for Women are sterile, single-use, hydrophilic intermittent urinary catheters intended for bladder drainage in patients requiring intermittent catheterization due to urinary retention or dysfunction. The devices feature FeelClean Technology for improved lubricity and patient comfort.

The devices are hydrophilic thermoplastic elastomer (TPE) tubes with polyvinyl chloride (PVC) funnels for the men's and glide versions, and high-density polyethylene (HDPE) funnel for the women's version. They feature two smooth eyelets, straight or coudé tips, and are available in multiple sizes (CH08–CH18 range). A minor change includes adjustment of eyelet tolerance from ±0.2 mm to ±0.3 mm and removal of a trace additive from the women's funnel material.

Not stated in this summary. The document references ISO 13485 quality management requirements but does not cite specific ISO, IEC, or ASTM test standards for performance validation.

The devices are substantially equivalent because they share the same fundamental intended use, design, and technological characteristics as their predicate devices (K213283, K181206, K232665). Performance testing including friction coefficient, insertion/withdrawal force, sterilization validation, and post-market patient comfort data support equivalence. Modifications to sterilization method, material formulation, and eyelet tolerances do not alter fundamental safety or effectiveness.