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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 betweeen patient and examiner.

Non sterile, Powder free Nitrile Examination Glove, Blue ,Polymer coating with Chemotherapy claim .

{
  "acceptance_criteria_and_performance_table": {
    "title": "Acceptance Criteria and Device Performance for Non-Sterile, Power-Free Nitrile Examination Glove",
    "headers": ["CHARACTERISTICS", "STANDARDS", "DEVICE PERFORMANCE"],
    "data": [
      ["Dimensions", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Physical Properties", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Freedom from pinholes", "ASTM D 6319-00a (Re-approved 2005)", "Meets"],
      ["Powder Free Residue", "ASTM D 6124-2006", "≤ 2 mg/glove"],
      ["Biocompatibility (Primary Skin Irritation in Rabbits)", null, "Passes"],
      ["Biocompatibility (Guinea Pig Sensitization)", null, "Passes"]
    ]
  },
  "sample_size_test_set": "Not specified; the document refers to performance data but does not detail the sample sizes for the specific tests.",
  "data_provenance": "Not specified explicitly in the provided text. The submitter is Siam Sempermed Corp., Ltd from Thailand, suggesting testing could have occurred there or in the US.",
  "number_of_experts_ground_truth_test_set": "Not applicable. The tests performed are objective, laboratory-based physical and chemical property assessments according to ASTM standards, and biocompatibility tests. Expert consensus is not required for establishing ground truth for these types of measurements.",
  "qualifications_of_experts": "Not applicable.",
  "adjudication_method": "Not applicable. The tests involve quantifiable measurements against established standards, not subjective assessments requiring adjudication.",
  "mrmc_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data.",
  "effect_size_of_human_readers_with_ai_vs_without_ai_assistance": "Not applicable, as no MRMC study was performed and this device type does not involve AI assistance for human reader interpretation.",
  "standalone_performance_study": "Yes, a standalone (algorithm only without human-in-the-loop performance) was effectively done. The device's performance was evaluated against established ASTM and biocompatibility standards independently, without human interaction with an AI component.",
  "type_of_ground_truth_used": "Objective measurements from laboratory tests according to established international standards (ASTM) and biological response tests (biocompatibility).",
  "sample_size_training_set": "Not applicable. This device is a medical glove, not an AI/ML-based device that requires a training set.",
  "how_ground_truth_for_training_set_was_established": "Not applicable, as there is no training set for this device type."
}

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