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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.

SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color.

The provided text {0} {1} {2} is an FDA 510(k) clearance letter for a medical device: "SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color." This document primarily grants marketing clearance based on substantial equivalence to a predicate device and outlines general regulatory obligations.

Crucially, this document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.

Therefore, I cannot provide the requested information from the given text.

The closest information available is:

• Device Name: SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color.
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Regulatory Class: I
• Product Code: KGO
• Indications For Use: "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."

To fulfill your request, I would need a different document, such as the full 510(k) submission, a clinical study report, or a summary of safety and effectiveness, which would detail the specific performance testing and results conducted for this glove.

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