(78 days)
The Powder-Free Nitrile 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.
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for "Powder Free Nitrile Examination Gloves." These documents do not contain information related to software or AI-powered medical devices. Therefore, I cannot extract details about acceptance criteria or supporting studies for such a device.
The information you've requested (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in documentation for AI/Software as a Medical Device (SaMD) products, reflecting their performance evaluation.
This submission is for a Class I medical device (non-powdered patient examination glove), which is a physical product and does not involve AI or algorithms requiring the type of performance study details you've outlined.
§ 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.