{"data":{"id":"us/21-cfr-878.4014","jurisdiction":"us","citation":"21 CFR 878.4014","heading":"Nonresorbable gauze/sponge for external use.","body":"(a) Identification. A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart E—Surgical Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"c33317a953d5b4b92713f21137cfea10b20fef9a38d3312b2c07de5cf3e5d0ba","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4011","next":"us/21-cfr-878.4015"},"notice":"GroundRules: Original legal text. Not legal advice."}