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A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient.

Sterile Powder Free Synthetic Surgical Gloves with Polymer Coating

The provided text is a 510(k) premarket notification letter from the FDA regarding "Sterile Powder Free Synthetic Surgical Gloves with Polymer Coating." This document, while an important part of medical device regulation, does not contain the acceptance criteria or a study outlining device performance as requested.

The letter focuses on:

• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Classification: The device is classified as Class I (Surgeon's Glove) under regulation number 880.4460, product code KGO.
• Regulatory Requirements: It outlines the general controls provisions of the Act that the device must comply with (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
• Indications for Use: The glove is indicated for use by healthcare and similar personnel to prevent contamination between personnel and the patient.

Because the document is a regulatory approval letter and not a study report, it does not provide the specific information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot populate the table or answer the specific questions about a study from the given text.

Ask a specific question about this device