Search Results

This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Polymer Coated, Powder Free, Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or Less), White Color.

The provided text describes a 510(k) premarket notification for "Polymer Coated, Powder Free, Latex Examination Gloves White Color" by PT. Smart Glove Indonesia. It is a communication from the FDA to the manufacturer, indicating that the device has been found substantially equivalent to legally marketed predicate devices.

However, the document is a regulatory letter and an "Indication for Use Statement" page. It does not contain any information about acceptance criteria, a study proving the device meets these criteria, sample sizes, expert qualifications, ground truth, or any specifics of device performance testing beyond the FDA's substantial equivalence determination.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other details of a study based on the provided text. The document focuses on regulatory approval rather than technical study results.

Ask a specific question about this device