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A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (nitrile latex) that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.

A powder-free patient examination glove (nitrile) is a disposable device made of synthetic material (nitrile latex) that may bear a trace amount of glove powder and is intended to be worn on the hands or finger(s) for medical purposes to provide a barrier against potentially infectious materials and ntoal paiminants. The glove is black with a carbon black colorant additive and polymer coated.

This document is a 510(k) clearance letter for Powder-Free, Black, Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The letter confirms substantial equivalence to a predicate device, which is based on shared characteristics and performance attributes rather than a specific study outlined here.

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