(52 days)
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Disposable Powder Free Vinyl Polyurethane Coated Examination Gloves
This document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Examination Gloves" manufactured by Hong Huang Tang Industrial Company, Ltd. It determines the device is substantially equivalent to legally marketed predicate devices.
Based on the provided document, answering the requested questions is not possible.
Here's why:
- This is a 510(k) clearance letter for medical gloves, not an AI/software as a medical device (SaMD) study report. The document pertains to a physical medical device (gloves) and assesses its substantial equivalence to existing products, primarily based on material safety, manufacturing practices, and intended use as a barrier.
- The questions you've asked are specific to the evaluation of an AI or software-based medical device. They inquire about performance metrics (e.g., sensitivity, specificity), ground truth establishment, expert adjudication, multi-reader multi-case studies, and training/test set details, which are all relevant to the validation of AI algorithms.
Therefore, I cannot provide the information requested in your numbered list as the provided document does not contain any details about an AI device or its performance study.
The document merely states that the gloves "prevent contamination between healthcare personnel and patient" as their indication for use. No performance metrics, study designs, or data provenance related to an AI algorithm are present.
§ 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.