(18 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.
POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
This submission is for "POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE". The device is a Class I medical device (80LZA).
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| ASTM D 5250-00 | Met or exceeded |
| ASTM D 5151-00 | Met or exceeded |
| ASTM D 6124-00 | Met or exceeded |
| Bio-Burden | Met or exceeded |
| Bio-Compatibility: Dermal Sensitization | Met or exceeded |
| Primary Skin Irritation | Met or exceeded |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The studies refer to meeting or exceeding ASTM standards and biocompatibility tests, which imply a defined methodology within those standards for sample selection and testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The device is an examination glove, and its performance is assessed against technical standards (ASTM) and biological safety tests (biocompatibility, bio-burden), rather than requiring expert interpretation of diagnostic output to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device and study. The testing involves laboratory measurements against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human readers interpret medical images or data. The device in question is an examination glove.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical product (examination glove), not an algorithm or AI system. Its performance is assessed through physical and biological testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by the specifications and pass/fail criteria outlined in the referenced ASTM standards (D 5250-00, D 5151-00, D 6124-00) and the acceptable levels for Bio-Burden, Dermal Sensitization, and Primary Skin Irritation. These standards represent scientifically established benchmarks for glove quality and safety.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this 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.