(196 days)
A patient examination glove is a disposable device intended for A pation. Oxamillian worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Non sterile, Powdered Nitrile Examination Glove, Blue
The provided document is a 510(k) summary for a Non-Sterile, Powdered Nitrile Examination Glove, Blue. It describes the device's characteristics and its substantial equivalence to a predicate device, rather than a study with acceptance criteria and device performance in the context of an AI or diagnostic medical device.
Therefore, many of the requested elements are not applicable to this type of submission. However, I can extract the information that is present and clearly state where the requested information is not available due to the nature of the document.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in the typical sense of a diagnostic or AI device (e.g., sensitivity, specificity thresholds). Instead, it refers to industry standards that the device "meets" or "passes."
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a-05 | Meets |
| Physical Properties | ASTM D 6319-00a-05 | Meets |
| Freedom from Pinhole | ASTM D 6319-00a-05 | Meets |
| Powder Residue | ASTM D 6319-00a-05 | Meets |
| Biocompatibility | Primary Skin Irritation in Rabbits | Passes |
| Guinea Pig Sensitization | Passes |
(Note: The term "acceptance criteria" here refers to the standards against which the glove's performance was measured.)
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for testing each characteristic (Dimensions, Physical Properties, Biocompatibility, etc.). It only states that the device "Meets" or "Passes" the listed standards.
Regarding data provenance, no information is provided about the country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable to a glove's performance testing for physical and biocompatibility characteristics. The "ground truth" for these measurements would be defined by the ASTM standards and expert interpretation of the test results according to those standards, not by clinical expert consensus in the way it applies to diagnostic image analysis.
4. Adjudication Method for the Test Set
This information is not applicable as it relates to expert consensus or interpretation for data labeling, which is not relevant for the type of testing described for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or is mentioned, as this device is a patient examination glove and not an AI or diagnostic imaging device that would typically involve human readers interpreting cases.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical product (glove) and does not involve an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on the objective measurements and established protocols defined within the ASTM D 6319-00a-05 standard for physical properties and freedom from pinholes, and standardized laboratory animal testing protocols for biocompatibility (Primary Skin Irritation in Rabbits and Guinea Pig Sensitization). It's not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. Sample Size for the Training Set
Not applicable. This device is not an AI or machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.