(57 days)
A patient examination glove is a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner.
POWDER-FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
This appears to be a 510(k) premarket notification letter from the FDA, along with an "ANNEXURE 'A'" which is a "GLOVE REVIEW SUMMARY." This document does not describe a study proving a device meets acceptance criteria in the manner typically expected for AI/ML medical devices.
The context here is for a Powder-Free Latex Examination Gloves, Polymer Coated With Protein Content Labeling Claim (50 Micrograms or Less). The FDA's letter states that they have determined the device is substantially equivalent to legally marketed predicate devices. This means the manufacturer has demonstrated that their new device is as safe and effective as a device already on the market.
Therefore, the requested information about acceptance criteria, studies, sample sizes, experts, adjudication, MRMC studies, standalone performance, ground truth, and training sets is not applicable in this context. These are typically elements of validation studies for novel medical devices, especially AI/ML-driven ones, where new performance claims are being made.
For a 510(k) submission for a traditional, non-AI/ML device like examination gloves, the demonstration of substantial equivalence usually involves:
- Comparison to a Predicate Device: Showing the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a lawfully marketed predicate device.
- Performance Testing: This would typically involve physical and chemical testing of the gloves themselves to ensure they meet established standards (e.g., ASTM standards for barrier integrity, dimensions, tensile strength, protein content, etc.). The "acceptance criteria" would be defined by these standards.
Without a specific study described in the provided text, I cannot fill out the requested table or provide the detailed information. The document confirms that the device has met the requirements for substantial equivalence, which implies that appropriate testing and comparisons were performed to satisfy the FDA.
§ 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.