(99 days)
The Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Powder Free Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and include variations of different sizes from X-Small to X-large. The color of the proposed device is Blue and Indigo
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
The provided document is a 510(k) Pre-Market Notification for a Powder Free Nitrile Examination Glove. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a study proving the device meets acceptance criteria for an AI/CADe system. Therefore, I cannot provide details related to AI/CADe specific criteria such as ground truth, expert adjudication, or MRMC studies.
However, I can extract the acceptance criteria and reported device performance for the glove itself, based on the non-clinical tests described in Section 8.0, "Summary of Non-Clinical Testing."
Here is the requested information for the medical glove, structured as closely as possible to your prompt, while acknowledging the limitations of the provided document for AI/CADe specific questions:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria (Proposed Device) | Reported Device Performance (Proposed Device - Blue/Indigo) |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes (AQL: 1.5) | No water leakage inspected from 200 samples. |
| ASTM D6124 | Determine the powder residue for powder free gloves |
§ 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.