(103 days)
The H2H Powder Free Nitrile Examination Blue Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.
H2H Powder Free Nitrile Examination Blue Gloves
The provided text is a 510(k) premarket notification letter for "H2H Powder Free Nitrile Examination Blue Gloves." This document announces the FDA's determination of substantial equivalence for the device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in submissions for AI/ML-based medical devices or diagnostic tools.
The information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) pertains to the validation of performance characteristics for devices that make diagnostic or prognostic claims, or assist in such claims, often involving algorithms or image analysis.
For a Class I device like examination gloves, the 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device through evidence such as:
- Conformance to consensus standards: Such as ASTM standards for physical properties (tensile strength, elongation, puncture resistance, etc.), biocompatibility, and sterility (if applicable).
- Performance testing: In vitro laboratory tests to ensure the gloves meet specified physical properties, barrier integrity (e.g., freedom from holes), and absence of powder (if powder-free).
- Biocompatibility testing: According to ISO 10993 series.
- Labeling review: Ensuring appropriate instructions for use, warnings, and contraindications.
Since the provided text is a clearance letter for examination gloves, it does not include the detailed performance study information typically expected for a software or AI/ML device.
Therefore, I cannot extract the requested information from the provided document. The document concerns a physical medical device (gloves) and not a device that relies on complex algorithms or human interpretation of outputs that would necessitate such detailed performance validation studies.
§ 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.