(255 days)
A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Powder Free Vinyl Examination Gloves
This document is related to a 510(k) premarket notification for "Powder Free Vinyl Examination Gloves" and is a letter from the FDA to Shinemound Enterprise, Incorporated, confirming that their device is substantially equivalent to legally marketed predicate devices.
As such, this document does not contain information about acceptance criteria and a study that proves the device meets the acceptance criteria.
The document primarily focuses on:
- The FDA's determination of substantial equivalence (K971360).
- The regulatory classification of the device (Class I).
- General controls provisions applicable to the device.
- Contact information for various FDA offices.
- An "Indication For Use Statement" for the gloves.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this material.
§ 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.