Every piece of Personal Protective Equipment (PPE) meant to be used as a medical device must abide by FDA rules and adhere to relevant voluntary consensus criteria for safety. Surgical masks, N95 respirators, medical gloves, and gowns fall under this category. Depending on the exact type of PPE, different consensus standards and FDA criteria apply. The device's effectiveness and safety are reasonably assured when these norms and regulations are upheld.
It reduces the transfer of infection from one person to another when used correctly and in conjunction with other infection control techniques including hand washing, using alcohol-based hand sanitizers, and covering coughs and sneezes. In order to effectively use PPE and avoid exposing the wearer and others to infection, contaminated Personal Protective Equipment must be removed and properly disposed of. The Centers for Disease Control and Prevention (CDC) are in charge of formulating precise recommendations for infection control measures to be taken in various situations and settings when an infection outbreak affects a significant portion of the American population.
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