Search Results

Latex Examination Glove is a disposable medical device intended for medical handling purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the blood, other body fluids, mucous membranes, or non-intact skin of patient.

Not Found

I am sorry, but based on the provided document, I cannot answer the request as it pertains to a regulatory letter regarding the marketing of "Multi-Comfort Powdered Examination Gloves" and does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document discusses the substantial equivalence of the gloves to previously marketed devices and outlines regulatory compliance for manufacturing and labeling.

Ask a specific question about this device