FDA authorizes COVID-19 emergency use of protective gowns, other apparel

May 28, 2020 - 03:26 PM
FDA-guidance

The Food and Drug Administration this week authorized the emergency use of certain personal protective equipment to help address insufficient supply due to the COVID-19 pandemic. FDA is allowing health care personnel to use the following otherwise-unapproved items, provided there is “no adequate, approved, and available alternative” during the COVID-19 public health emergency:

  • conductive shoes and shoe covers;
  • operating-room shoes;
  • surgical apparel accessories;
  • non-surgical isolation gowns;
  • operating-room shoe covers;
  • surgical helmets; and
  • surgical caps.

These gowns and other apparel are authorized under the emergency use authorization when intended for use by health care personnel in health care settings, and in accordance with Centers for Disease Control and Prevention recommendations to protect personnel and patients from the transfer of SARS-CoV-2 in low- or minimal-risk-level situations. This includes authorized gowns and other apparel decontaminated using a decontamination system that has been issued an EUA.

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