(146 days)
A patient Examination Powder-Free Chlorinated 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.
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This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves" (K973020). It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance, studies conducted, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) submission itself, or in supporting documentation, not in the clearance letter.
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§ 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.