Medical devices; patient examination glove; revocation of exemptions from the premarket notification procedures and the current good manufacturing practice regulations--FDA. Final rule.
The Food and Drug Administration (FDA) is revising the patient examination glove classification regulation, set forth in 21 CFR 880.6250, by revoking exemptions from the premarket notification procedures and certain current god manufacturing practice (CGMP) requirements identified in the regulation. The revocations are necessary because of the importance of this device in helping to prevent the transmission between patients and health-care workers of the HIV (human immunodeficiency virus) virus that causes AIDS (acquired immunodeficiency syndrome).
D000056:Accident Prevention; D000163:Acquired Immunodeficiency Syndrome / Q000517:prevention & control*; D005932:Gloves, Surgical / Q000592:standards*; D006801:Humans; D010564:Personnel, Hospital; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration