Search Results

A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL AND OTHER CONTAMINANTS.

A POWDER FREE PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX OR SYNTHETIC MATERIAL THAT MAY BEAR A TRACE AMOUNT OF GLOVE POWDER IS INTENDED TO BE WORN ON THE HAND OR FINGER (S) FOR MEDICAL PURPOSE TO PROVIDE A BARRIER AGAINST POTENTIALLY INFECTIOUS MATERIAL AND OTHER CONTAMINANTS.

The provided document is a 510(k) clearance letter from the FDA for a Glove Powder Free Patient Examination, Latex manufactured by Lalan Glove (PVT) Limited. This document does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML-driven medical device.

The letter explicitly states that the device is a "Glove Powder Free Patient Examination, Latex" and details its regulatory classification and the process for substantial equivalence. It refers to general controls, good manufacturing practices, and labeling requirements for medical devices.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, etc.) for an AI/ML device from this document.

Ask a specific question about this device