Regulation Text
(a) Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
(b) Classification. Class II (performance standards).
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.