(35 days)
A 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.
POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ
This is a 510(k) Summary for Powdered Vinyl Exam Gloves.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00E4 | Met or exceeded standard |
| ASTM D 5151-99 | Met or exceeded standard |
| ASTM D 6124-01 | Met or exceeded standard |
| ISO 2859 | Met or exceeded standard |
| MIL Std 105E | Met or exceeded standard |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded standard |
| Bio-Compatibility: Primary Skin Irritation | Met or exceeded standard |
| Bio-Burden (Procedure Method 8315) | Met or exceeded standard |
2. Sample Size for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the evaluations were based on standardized performance tests rather than expert interpretation of medical data or images.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations were based on standardized performance tests rather than human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this device is a medical glove, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not conducted as this device is a medical glove, not an algorithm.
7. Type of Ground Truth Used
The ground truth used was based on the objective measurements and pass/fail criteria defined by the listed industry and regulatory standards (ASTM, ISO, MIL Std, and bio-compatibility tests).
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a training set. The "ground truth" for demonstrating performance was established by the predefined specifications within the referenced ASTM, ISO, and MIL standards, and bio-compatibility testing procedures.
§ 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.