On May 22, 2020, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of non-surgical gowns and other apparel for use by health care personnel (HCPs) as personal protective equipment (PPE) for use in health care settings. FDA intends for the EUA to increase the availability of currently marketed and new non-surgical gowns and other apparel for a medical purpose during the COVID-19 pandemic.
The EUA includes the types of non-surgical gowns and other apparel used in accordance with Centers for Disease Control and Prevention (CDC) recommendations to protect both HCP and patients in low or minimal risk level situations to help prevent the spread of COVID-19.1 Gowns and other apparel included in the EUA’s scope are identified in the table below:
| 21 CFR 878.4040 |
Conductive shoe and shoe cover |
BWP
|
I (exempt) |
| 21 CFR 878.4040 |
Operating-room shoes |
FXW |
I (exempt) |
| 21 CFR 878.4040 |
Surgical apparel accessory |
LYU |
I (exempt) |
| 21 CFR 878.4040 |
Non-surgical isolation gown |
OEA |
I (exempt) |
| 21 CFR 878.4040 |
Operating-room shoe cover |
FXP |
I (exempt) |
| 21 CFR 878.4040 |
Surgical helmet |
FXZ |
I (exempt) |
| 21 CFR 878.4040 |
Surgical cap |
FYF |
I (exempt) |
FDA also included as part of this EUA gowns and other apparel that have been decontaminated pursuant to the terms and conditions of an authorized discontinuation system. Furthermore, in the circumstances of this public health emergency, FDA has authorized HCPs to use the gowns and other apparel covered by the EUA when treating any patient, not only when treating patients with suspected or confirmed COVID-19.
The following items are outside the scope of the EUA:
- Class I (reserved) and II devices such as surgical gowns (product code: FYA) and surgical isolation gowns (product code: FYC)
- Gowns intended to provide Level 3 or Level 4 liquid barrier protection or equivalent under the FDA-recognized standard ANSI/AAMI PB70: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
The EUA identifies additional requirements such as proper labeling and meeting “minimal-to-low barrier protection,” which means Level 1 or Level 2 protection or equivalent under ANSI/AAMI PB70. No printed matter relating to the use of the authorized gown or other apparel may represent or suggest that the authorized product is safe or effective for the prevention or treatment of patients during the COVID-19 pandemic.
Refer to the full text of the EUA for a complete description of requirements and responsibilities.
Since the advent of the COVID-19 public health emergency, FDA has granted the following PPE-related EUAs:
FDA also has issued guidance on its enforcement discretion for face masks and respirators, gowns, other apparel, and gloves, and a temporary policy for manufacturing hand sanitizer products.
FOOTNOTES
- Please see FDA’s letter to Health Care Providers entitled “Surgical Mask and Gown Conservation Strategies” and CDC’s “Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings” guidance for more information.
