(49 days)
Powdered Latex Examination Gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
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This document is a 510(k) clearance letter for "Top Glove Medical Powdered Latex Examination Gloves." As such, it's a regulatory approval document for a medical device (examination gloves), not a study report for an AI/ML diagnostic device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies cannot be extracted from this document, as these concepts are specific to the evaluation of AI/ML diagnostic tools and are not applicable to the clearance of examination gloves.
The document primarily focuses on:
- Device Identification: Top Glove Medical Powdered Latex Examination Gloves, Regulation Number 880.6250, Product Code LYY.
- Regulatory Status: Substantially equivalent to legally marketed predicate devices, allowing the device to be marketed.
- Intended Use: Worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.
- Compliance: Compliance with general controls provisions of the Act (registration, listing, GMP, labeling, etc.).
§ 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.