(211 days)
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.