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510(k) Data Aggregation
(121 days)
A Powder Free Surgeon's Glove is intended to be worn on the hands, usually in surgical settings to provide a barrier against potentially infectious materials and other contaminants.
Powder Free Sterile Latex Surgical Gloves - Polymer Coated (With Protein Labeling Claim)
The provided text is a set of FDA letters regarding the 510(k) premarket notification for "Powder Free Sterile Latex Surgical Gloves - Polymer Coated (with Protein Labeling Claim)".
This document does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), MRMC studies, or standalone algorithm performance.
The letters only confirm the FDA's review and determination of substantial equivalence to legally marketed predicate devices, allowing the manufacturer to market the device. It also details regulatory classifications and requirements, and defines the "Indications for Use" for the gloves as providing "a barrier against potentially infectious materials and other contaminants" in surgical settings.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
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(100 days)
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