Medical devices; patient examination and surgeons' gloves; adulteration--FDA. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to: (1) Define adulteration for patient examination and surgeons' gloves; and (2) establish the sample plans and test method the agency will use to determine if these gloves are adulterated as defined by the rule. With the prevalence of human immunodeficiency virus (HIV) infection and the risk of clinical transmission of other infections, the importance of the quality of an effective barrier to the transmission of infection in health care settings is crucial. The public health will benefit through improved quality control of these protective barriers.
D003428:Cross Infection / Q000517:prevention & control*; D004868:Equipment Failure; D005932:Gloves, Surgical / Q000592:standards*; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence*; D008422:Materials Testing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration