(358 days)
The powder free vinyl patient examination glove (non-sterile) is a disposable device intended for medical purposes that is worn on the examiner's hand or fonger to prevent contamination between patient and examiner. It is sold as non sterile.
Powder Free Vinyl Patient Examination Gloves (Non-Sterile), that meets all of the requirement of ASTM standard D 5250-06e1, except for sterility requirements.
This document is a 510(k) Pre-market Notification Summary for Powder-Free Vinyl Patient Examination Gloves (Non-Sterile). It details the device, its intended use, and substantial equivalence to a predicate device.
Here's the information extracted and organized to address your request:
Acceptance Criteria and Device Performance Study
The testing described in the document is for a medical glove, which is a physical device, not an AI/software medical device. Therefore, many of the typical acceptance criteria and study descriptions for AI/software (e.g., human-in-the-loop, MRMC studies, ground truth establishment with experts, training/test set sizes for algorithms) do not apply.
The device's performance is gauged against established ASTM (American Society for Testing and Materials) standards for patient examination gloves. The "acceptance criteria" are these ASTM standards and the "study" is the nonclinical testing performed to show conformity.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | Meets ASTM D 5250-06e1 | Meets ASTM D 5250-06e1 |
| Physical Properties | Meets ASTM D 5250-06e1 | Meets ASTM D 5250-06e1 |
| Freedom from pinholes | Meets ASTM D5151-06 (Water Leak Test) | Meets ASTM D5151-06 / 21 CFR 800.20 |
| Powder Residual | Meets ASTM D5250-06e1 and D6124-01 | Meets ASTM D5250-06e1 and D6124-01 |
| Biocompatibility | Passes (Implied standard for safety) | |
| Primary Dermal Irritation | N/A (Standard test for safety) | Passes (in rabbits) |
| Dermal Sensitization | N/A (Standard test for safety) | Passes (in guinea pig) |
Note: The predicate device performance is also stated as meeting these same standards, indicating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of gloves tested) for each specific test (e.g., pinholes, tensile strength) conducted for this particular 510(k) submission. These would be defined by the relevant ASTM standards.
Data Provenance: The testing was conducted by the manufacturer, Lifestyle Safety Products (Hui Zhou) Co., Ltd, in Hui Zhou City, Guang Dong Province, China. The testing is non-clinical performance evaluation, not patient-derived data, so "retrospective or prospective" doesn't directly apply in the usual clinical
AI sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable as the device is a physical glove, not an AI/software device requiring "ground truth" established by human experts in the medical imaging/diagnostic sense. The "ground truth" here is objective measurement against engineering and material science standards (ASTM).
4. Adjudication Method for the Test Set
Not applicable for a physical device being tested against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This is a non-AI/software device. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like diagnosis or image interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective engineering and material science measurements against:
- ASTM (American Society for Testing and Materials) standards (e.g., D5250-06e1 for dimensions and physical properties, D5151-06 for freedom from pinholes, D6124-01 for powder residual).
- Biocompatibility tests on animal models (rabbits and guinea pigs) as per standard safety protocols.
- FDA regulations (e.g., 21 CFR 800.20 for pinholes).
8. The Sample Size for the Training Set
Not applicable. This is a manufactured product, not an AI model requiring a training set. The manufacturing process is controlled by Good Manufacturing Practices (GMP).
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set as it's not an AI model.
§ 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.