Search Results

BrightwayTM Brand Polymer Coated Latex Examination Glov Powder Free containing 50 micro grams or less of water extractab protein per gram is a disposable patient examination glove which worn on the hand of healthcare and similar personnel to prever contamination between patient and examiner.

BrightwayTM Brand . Polymer Coated La Examination Gloves, Powder Free containing µgm or less of water extractable protein per gram.

The provided text is a 510(k) clearance letter from the FDA for medical gloves, and it does not contain any information about acceptance criteria or a study proving device performance in the context of medical device software, AI, or diagnostic tools.

Therefore, I cannot provide the requested information in the format specified because the document does not describe:

• Acceptance criteria for a device's performance metrics (e.g., sensitivity, specificity, accuracy).
• A study's methodology, results, or data provenance.
• Details about test sets, training sets, ground truth establishment, or expert involvement.

The document essentially states that the "Brightway™ Brand Polymer Coated Latex Examination Glove Powder-Free" is substantially equivalent to legally marketed predicate devices. This equivalence is based on the device's characteristics and intended use, not on performance metrics derived from a study comparing its analytical or clinical performance against acceptance criteria.

Ask a specific question about this device