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A non sterile powder free latex exam glove intended for medical purposes that is worn on the examiner's hands to prevent contamination between the patient and examiner.

SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP WITH A PROTEIN CLAIM OF 50 MICROGRAM OR LESS PER GRAM OF GLOVE

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device: "Single Use, Disposable, Blue Color, Powder Free Latex Patient Examination Glove with Colloidal Oatmeal USP with a Protein Claim of 50 Microgram or Less Per Gram of Glove."

This document does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

Instead, the letter:

• Confirms the FDA has reviewed the 510(k) submission (K072802).
• Determines the device is "substantially equivalent" to legally marketed predicate devices.
• Grants permission to market the device under general controls.
• Specifies the regulatory class (Class I) and product code (LYY).
• Outlines general regulatory compliance requirements.
• Includes an "Indications for Use Statement" for the glove.

Therefore, I cannot provide the requested information from this document. The document primarily serves as an FDA clearance letter based on substantial equivalence, not a detailed report of device performance studies.

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