(60 days)
LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color) is a disposable patient examination glove which is worn on the hand of a healthcare and similar personnel to prevent contamination between patient and examiner.
LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free - Blue Color)
The provided text is a 510(k) Premarket Notification from the FDA for medical gloves. It does not contain any information about a study that proves a device meets acceptance criteria in the way you've described for AI/medical imaging devices.
The document is a regulatory approval for "LaGlove™ Brand Double Polymer Coated Nitrile Examination Gloves (Powder Free-Blue Color)", establishing its substantial equivalence to legally marketed predicate devices. This type of regulatory submission for Class I medical devices like examination gloves primarily focuses on:
- Manufacturing standards: Ensuring the gloves are produced under good manufacturing practices.
- Material safety: Demonstrating the materials used are safe for patient contact.
- Performance specifications: Meeting established physical properties for gloves (e.g., tensile strength, puncture resistance, freedom from holes).
The details you've requested (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are typical for the evaluation of diagnostic devices, especially those utilizing AI or complex algorithms for image analysis or disease detection.
Therefore, I cannot provide the requested information based on the provided text because it is not relevant to the type of device and regulatory submission discussed.
To reiterate, this document is a letter from the FDA granting clearance for a physical medical device (examination gloves), not a report on a clinical or performance study involving complex data analysis or AI.
§ 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.