When packaged as pairs, each glove is considered separately, and both gloves will be analyzed.
Each medical glove will be analyzed independently. For the purposes of this part, FDA's analysis of gloves for leaks and visual defects will be conducted by a visual examination and by a water leak test method, using 1,000 milliliters (ml) of water. (2) For a description of a surgeons' glove, see § 878.4460 of this chapter. Finger cots, however, are excluded from the test method and sample plans in paragraphs (b) and (c) of this section. (1) For a description of a patient examination glove, see § 880.6250. Therefore, FDA, through this regulation, is defining adulteration for patient examination and surgeons' gloves as a means of assuring safe and effective devices. Among other things, CDC's recommendation that health care providers wear medical gloves demonstrates the proposition that devices labeled as medical gloves purport to be and are represented to be effective barriers against the transmission of blood- and fluid-borne pathogens.
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The CDC recommends that health care workers wear medical gloves when touching blood or other body fluids, mucous membranes, or nonintact skin of all patients when handling items or surfaces soiled with blood or other body fluids and when performing venipuncture and other vascular access procedures. The Centers for Disease Control (CDC) recommend that health care workers wear medical gloves to reduce the risk of transmission of HIV and other blood-borne infectious deseases. The prevalence of human immunodeficiency virus (HIV), which causes acquired immune deficiency syndrome (AIDS), and its risk of transmission in the health care context, have caused the Food and Drug Administration (FDA) to look more closely at the quality control of barrier devices, such as surgeons' gloves and patient examination gloves (collectively known as medical gloves) to reduce the risk of transmission of HIV and other blood-borne infectious diseases. 800.20 Patient examination gloves and surgeons' gloves sample plans and test method for leakage defects adulteration. Subpart B - Requirements for Specific Medical Devices
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The information on this page is current as of Mar 29, 2022.įor the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
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