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The Powder Free Patient Examination Gloves is a disposable device made of natural rubber latex that may bear a trace amount of glove powder and is intended to be worn on the hand for medical purposes to provide a barrier against potential infectious materials and other contaminants.

Powder Free Latex Examination Gloves

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) substantial equivalence letter for "Powder Free Latex Examination Gloves" and does not contain information about specific performance acceptance criteria or details of a study conducted to demonstrate the device meets such criteria.

The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. It does not include efficacy or performance study details.

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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 examiner.

Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (

This document describes the acceptance criteria and performance of Powder Free, Natural and/or Colored Latex Exam Gloves, with Protein labeling (

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