Search Results

A black, powder free and polymer coated latex examination glove is a disposable device made of natural latex that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants. A black pigment is added to the latex in the production process to produce the black colored glove.

Black, Powder Free and Polymer Coated Latex Examination Glove with a Protein Claim of Less Than 50 µg/gm Glove

The provided text is a 510(k) premarket notification letter from the FDA regarding a "Black, Powder Free and Polymer Coated Latex Examination Glove with a Protein Claim of Less Than 50 µg/gm Glove."

This document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an Artificial Intelligence (AI) or software as a medical device (SaMD) product.

Instead, it is a regulatory clearance letter for a physical medical device (medical glove). The "acceptance criteria" and "study" mentioned in your request are typically relevant to the performance evaluation of AI/SaMD, where metrics like sensitivity, specificity, AUC, and clinical effectiveness are assessed.

For this physical device, the "acceptance criteria" would refer to manufacturing standards, biocompatibility, barrier integrity (e.g., freedom from holes), tensile strength, and protein content. The "study" would be testing conducted to demonstrate compliance with these standards, not a clinical trial in the sense of AI performance evaluation.

Therefore, I cannot provide the requested information based on the input text because it does not pertain to an AI/SaMD product.

Ask a specific question about this device