(147 days)
A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.
The Powder-Free Nitrile Examination Gloves, Orange is substantial equivalent to Powder-Free Nitrile Examination Gloves, Black Color with 510k number K090194 that is currently marketed. The device modification is a change in color from Black to Orange. Another device modification is the addition of adding a citric acid coating to the interior surface of the gloves to achieve a pH of 5.0 - 5.5 for the inner surface of the glove.
The provided document is a 510(k) Summary for Powder-Free Nitrile Examination Gloves, Orange Color. It describes the device, its intended use, and a summary of technological characteristics compared to standards. The document does not describe a study in the context of an AI/ML medical device with the information requested (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, or specific ground truth types like pathology or outcomes data).
Instead, this document is a submission to the FDA demonstrating substantial equivalence for a medical device (gloves) by confirming its compliance with established performance standards.
Therefore, many of the requested fields cannot be filled from the provided text as they are not applicable to this type of device submission.
Here's an attempt to answer based on the provided document, using "N/A" where information is not present or not relevant to the type of device:
1. Table of acceptance criteria and the reported device performance
| Characteristics | Standards (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D6319-10 | Meets |
| Physical Properties | ASTM D6319-10 | Meets |
| Freedom from pinholes | ASTM D6319-10 / FDA 21 CFR 800.20 | Meets, AQL 2.5 |
| Powder-Free | ASTM D 6124-06 | Meets |
§ 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.