(46 days)
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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.