(96 days)
A 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 examiners.
Pre-powdered Latex Examination Gloves Powdered with Oat Starch Powder
This document is a 510(k) summary for a pre-powdered latex examination glove. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The document is a clearance letter from the FDA to Pamitex Industries Sdn. Bhd. for their "Pre-Powdered Latex Examination Glove with Trade Name: Oat-Starch Powder." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot provide the requested information from this document. The questions you posed are typically relevant to the performance evaluation of AI/ML software as a medical device, which is not what this document addresses.
§ 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.