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The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are made of synthetic rubber lates intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

The provided document describes the acceptance criteria and performance of Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour. The study detailed is aimed at demonstrating substantial equivalence to a legally marketed predicate device (K032942) for 510(k) clearance.

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1. Table of Acceptance Criteria and Reported Device Performance

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