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§878.4040. Surgical apparel. — Inbound Citations

21 C.F.R. § 878.4040

Cited by 1 regulation in release Current.

Citations to 21 C.F.R. § 878.4040 as a whole

  • (ii) Direct patient care means hands-on, face-to-face contact with patients for the purpose of diagnosis, treatment, and monitoring.
    Disinfect/disinfection means using an EPA-registered, hospital-grade disinfectant on EPA's “List N” (incorporated by reference, § 1910.509), in accordance with manufacturers' instructions to kill germs on surfaces.
    Elastomeric respirator means a tight-fitting respirator with a facepiece that is made of synthetic or rubber material that permits it to be disinfected, cleaned, and reused according to manufacturer's instructions. It is equipped with a replaceable cartridge(s), canister(s), or filter(s).
    Facemask means a surgical, medical procedure, dental, or isolation mask that is FDA-cleared, authorized by an FDA EUA, or offered or distributed as described in an FDA enforcement policy. Facemasks may also be referred to as “medical procedure masks.”
    Face shield means a device, typically made of clear plastic, that: