(50 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient.
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES. WITH WATER EXTRACTABLE PROTEIN LABELLING CLAIN 100 micron or lease of tatal with extracts
The provided document is a 510(k) premarket notification letter from the FDA to Alliance Rubber Products Sdn. Bhd. for "Polymer Coated Powder Free Latex Examination Gloves." This document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment for an AI/ML powered device.
It is a clearance letter for a medical device (latex examination gloves) and primarily discusses:
- The FDA's determination of substantial equivalence for the gloves to legally marketed predicate devices.
- Regulatory classifications and general controls applicable to the device.
- Instructions for the company regarding marketing, labeling, and other regulations.
- The intended use of the gloves, which is "a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and the patient."
Therefore, I cannot provide the requested information based on this document.
§ 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.