title: Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove. Final rule.
abstract: The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.
mesh_terms: D000075202:Contraindications; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D005932:Gloves, Surgical / Q000009:adverse effects; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D054327:Lubricants / Q000009:adverse effects; D061214:Patient Safety / Q000331:legislation & jurisprudence; D011208:Powders / Q000009:adverse effects*; D012307:Risk Factors; D013523:Surgical Equipment / Q000331:legislation & jurisprudence*; D014481:United States
chemical_list: D054327:Lubricants; D011208:Powders