Description

This bristle-free oral foam swab from BALLARD by Avanos features a soft, gentle foam tip on a paper handle, individually pouch-wrapped for hygiene. Designed for single-use, non-sterile care, the paper-handle variant provides a secure grip and control during oral care routines. It is intended to apply mouth moisturizers to the lips and oral cavity and to wipe teeth and oral soft tissues for patients who require assistance with daily oral hygiene.

Intended Purpose

• Application of mouth moisturizers to lips and oral mucosa
• Wiping of teeth, tongue, gums, and other oral soft tissues
• For patients needing assistance with oral care

Key Features

• Bristle-free foam tip for comfort and gentle cleaning
• Individually wrapped to support hygienic handling at point of care
• Paper handle designed for secure grip and easy maneuverability
• Single-use, non-sterile device

Specifications

• Variant: Paper-handle oral foam swab (bristle-free)
• Handle length: Approximately 12 cm
• Wrapping: Individually pouch-wrapped

Packaging

• 250 swabs per dispenser box
• Case configuration: 4 dispensers per case (total 1000 swabs)

Regulatory and Compliance

• EU MDR classification: Class I (non-sterile, non-measuring) per Rule 5
• Conformity assessment: Annex IX
• Self-declared compliance with Regulation (EU) 2017/745

Important Use Notes

• Single-use only; dispose of after one patient contact
• Not a substitute for toothbrushing when mechanical plaque removal is required
• Use according to facility protocols and clinician judgment

Manufacturer and EU Authorized Representative

• Manufacturer: Avanos Medical, Inc., 5405 Windward Parkway, Alpharetta, GA 30004, USA
• EU Authorized Representative: Avanos Medical Belgium BVBA, Leonardo Da Vincilaan 1, 1930 Zaventem, Belgium