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e-CFR data is current as of September 17, 2020

Title 44Chapter ISubchapter FPart 328 → §328.103


Title 44: Emergency Management and Assistance
PART 328—COVID-19 ALLOCATION ORDERS AND PRIORITY ORDER REVIEW UNDER THE DEFENSE PRODUCTION ACT


§328.103   Designation of covered materials.

(a) The Administrator has designated the following materials as “covered materials” under this part:

(1) Surgical N95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;

(2) PPE surgical masks, including masks that cover the user's nose and mouth and provide a physical barrier to fluids and particulate materials;

(3) PPE nitrile gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes; and

(4) Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and are classified by Surgical Gown Barrier Performance based on AAMI PB70.

(b) Upon determination that additional items are scarce and necessary for national defense, and that consideration under this allocation order is the only way to meet national defense requirements without significant disruption to the domestic markets, the Administrator may designate additional materials as “covered materials” in the list provided above. The Administrator will publish notice of these additional “covered materials” in the Federal Register.

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