RMH3 Dental Non-Woven Gauze Sponges, 4-Ply · 2" × 2" · 5,000/Pack

A gauze sponge is a strip, piece or pad of open woven or nonwoven mesh cotton cellulose, or a simple chemical derivative of cellulose, placed directly on a wound to absorb exudate. The same classification covers both sterile and nonsterile gauze, and excludes gauze with added drugs such as antimicrobial agents, added biologics such as growth factors, or material from animal sources.

The FDA classifies a saliva absorber — a device made of paper or cotton intended to absorb moisture from the oral cavity during dental procedures — as Class I (21 CFR 872.6050). Gauze has its own classification: a sterile or nonsterile strip, piece or pad of open woven or nonwoven mesh cotton cellulose, or a simple chemical derivative of cellulose, placed directly on a wound to absorb exudate, Class I (21 CFR 878.4014). Cotton or synthetic fiber in the shape of a ball or a pad, for applying medication to or absorbing small amounts of body fluid from a body surface, is classified separately again (21 CFR 880.5300).

The CDC defines a single-use device as one designed to be used on one patient and then discarded, not reprocessed for use on another patient. It names cotton rolls and gauze among the single-use items that should be sterile at the time of use for oral surgical procedures.

Sources: FDA 21 CFR 872.6050, Saliva absorber · FDA 21 CFR 878.4014, Nonresorbable gauze/sponge for external use · FDA 21 CFR 880.5300, Medical absorbent fiber · CDC, Guidelines for Infection Control in Dental Health-Care Settings — 2003 (MMWR 2003;52(RR-17)) · Rubber dam versus cotton roll isolation and the survival of composite restorations in primary molars, 2-year non-inferiority trial (BMC Oral Health 2022)