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This glove is a disposable device intended for medical purpose that is worn on the hand of examiner to prevent contamination between patient and examiner.

LATEX PATIENT EXAMINATION GLOVES, POWDER FREE

The provided text is related to an FDA 510(k) clearance for a medical device: "MaxiKleen-Latex Examination Glove Powder-Trade Name: Free", also referred to as "LATEX PATIENT EXAMINATION GLOVES, POWDER FREE".

The document indicates that the device is a Class I medical device and has been determined to be substantially equivalent to legally marketed predicate devices. This means that the device's safety and effectiveness are established by its similarity to existing devices, and a comprehensive study designed to prove specific performance against detailed acceptance criteria, as one might see for a novel or higher-risk device, is not typically required or described in such 510(k) summary documents.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria, study specifics (sample size, data provenance, expert panels, adjudication, MRMC studies, standalone performance), or ground truth establishment for this specific 510(k) clearance. Such information is generally not part of a substantial equivalence determination for Class I devices like examination gloves.

The 510(k) process for this type of device relies on demonstrating equivalence to a predicate device, which implies that the predicate device's established safety and performance are sufficient.

However, I can extract the "Indications for Use" which serve as a high-level description of the device's intended purpose:

Indications For Use:
"This glove is a disposable device intended for medical purpose that is worn on the hand of examiner to prevent contamination between patient and examiner."

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