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A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.

Powdered Latex Examination Gloves (Protein Label Claim) (150 MICROGRAMS OR LESS)

This document is a 510(k) clearance letter from the FDA for Powdered Latex Examination Gloves. It primarily addresses the device's substantial equivalence to a predicate device and outlines general regulatory compliance.

Therefore, the document does not contain any information regarding:

• Acceptance criteria and reported device performance (in a table or otherwise)
• Sample sizes (test, training)
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance studies
• Type of ground truth used or how it was established

The letter confirms the device's classification as Class I, reiterates the general controls provisions of the Medical Device Amendments, and permits the marketing of the device. The "Indications For Use" section simply defines what a patient examination glove is and its function, which is standard for such a device.

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