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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.

Patient Examination Glove - Om Ni. FIT , LATEx TownEzFil EXAMINATION GLOVE.

This is a 510(k) premarket notification for a medical device (OMNI Fit Latex Examination Glove, Powdered). The provided text describes the regulatory approval process and states the intended use of the device. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment—which are typically found in a clinical study report or a more detailed section of a 510(k) submission that discusses performance data.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on:

• Regulatory Status: That the FDA has reviewed the 510(k) and determined the device is substantially equivalent to predicate devices.
• Device Classification: Class I.
• General Controls: Mentioning requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Contact Information: For regulatory advice.
• Indications for Use: Stating that the glove is "worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient."

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