![]() The Administrator will publish notice of these additional “covered materials” in the Federal Register. (b) Upon determination that additional items are scarce and necessary for national defense, and that consideration under the allocation order in this part 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 in paragraph (a) of this section. (ii) Hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act, Pub. (i) Piston syringes that allow for the controlled and precise flow of liquid as described by 21 CFR 880.5860, that are compliant with ISO 7886-1:2017 and use only Current Good Manufacturing Practices (CGMP) processes or (5) Syringes and hypodermic needles (whether distributed separately or attached together) that are either: (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 and ![]() (3) PPE nitrile gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes (ii) Class I or Class II flammability tests under CPSC CS 191-53, NFPA Standard 702-1980, or UL 2154 standards (2) PPE surgical masks as described by 21 CFR 878.4040, including masks that cover the user's nose and mouth providing a physical barrier to fluids and particulate materials, that meet fluid barrier protection standards pursuant to. (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 ![]() (a) The Administrator has designated the following materials as “covered materials” under this part: iv) the United States Code of Federal Regulations, Title 16, Section 1700.15. § 328.103 Designation of covered materials. 95 Child-resistant packaging requirements for medicines 2017 (TGO 95).
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