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Ex. AGY-FED-HEALTH-OTHER-054 Order Primary source read

Emergency Use Authorization: Gowns and Other Apparel (umbrella) (May 22, 2020)

Letter of Authorization, Gowns and Other Apparel

Denise M. Hinton, Chief Scientist, FDA · United States (federal); Food and Drug Administration (Federal)

The COVID Project

The record

Jurisdiction
United States (federal); Food and Drug Administration
Level
Federal
Authority
FD&C Act s. 564(c), (d)
Issued
2020-05-22 May 22, 2020
Effective
2020-05-22
End
Through the public health emergency (read as 2021-09-30)
In force
May 22, 2020 to Sept. 30, 2021
Quarters
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Health care ordersSupply chain
Addressees
  • manufacturers of gowns and apparel; health care personnel; purchasing departments and distributors
Functions reached
  • SC supply chain
  • PF production floor (apparel makers)
Collection
Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

I am authorizing the emergency use of certain gowns and other apparel, for use by HCP as PPE in health care settings, as described in the Scope of Authorization (Section II) and pursuant to the Conditions of Authorization (Section IV) of this letter.... HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials

Enforcement

Conditions of authorization