(112 days)
NO-POKES™ is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping.
The cap of the capped needle is placed in the NO-POKES™ . The "wax-like" substance in the NO-POKES™ holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKES™, the operator inserts the needle back into the cap without exposing his/her hand to the needle. The NO-POKES™ container has an adhesive on the base to hold it to the desired surface while in use.
NO-POKES™ is a disposable needle recapping aid that helps prevent recapping injury by providing repository for the needle cap (other than the user's hand) in which to place the cap while using the syringe. This keeps the user's hand away from the needle during uncapping and recapping.
The cap of the capped needle is placed in the NO-POKES™ . The "wax-like" substance in the NO-POKES™ holds the cap securely while the operator uses the needle. After the procedure, while the cap is secured in the NO-POKES™, the operator inserts the needle back into the cap without exposing his/her hand to the needle. The NO-POKES™ container has an adhesive on the base to hold it to the desired surface while in use.
The provided document is a 510(k) premarket notification letter from the FDA for a device called "No-Pokes Needle Safety Device (Recapper)". This document does not contain any information regarding acceptance criteria, study details, or performance data for the device.
Therefore, I cannot provide the requested information. The document focuses on the regulatory clearance of the device based on its substantial equivalence to a predicate device.
§ 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).