21 CFR § 880.5570 - Hypodermic single lumen needle.

---
identifier: "/us/cfr/t21/s880.5570"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 880.5570 - Hypodermic single lumen needle."
title_number: 21
title_name: "Food and Drugs"
section_number: "880.5570"
section_name: "Hypodermic single lumen needle."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "880"
part_name: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "45 FR 69682, Oct. 21, 1980, unless otherwise noted."
cfr_part: "880"
---


# 880.5570 Hypodermic single lumen needle.

(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).