(76 days)
Powder-free vinyl Examination glove, clear (non-colored) 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.
The Powder-free vinyl Examination glove, clear (Non-colored) is disposable device made PVC resin and plasticizers (DINP), Ca-Zn stabilizer, TXIB into film, coated with Polyurethane to facilitate donning and it intended to be worn on the hand of finger(s) for medical purpose to provide a barrier against potentially infectious materials and other contaminants.
This document describes the acceptance criteria and the study conducted for "POWDER-FREE VINYL EXAMINATION GLOVES, CLEAR (NON-COLORED)" by Quantum Co., Ltd.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D5250-06 "Standard Specification for Polyvinyl Examination Gloves for Medical Application" (includes physical properties like tensile strength, elongation, barrier integrity [e.g., freedom from holes]) | Gloves meet all the current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves. |
| 21 CFR 800.20 (Quality System Regulation for medical devices, which implicitly covers aspects like manufacturing controls) | Gloves meet all the current Specifications listed under the ASTM D5250-06 Standard Specification for Vinyl Examination Gloves. |
| Primary Skin Irritation testing (in rabbits) | No irritation. |
| Delayed Contact Sensitization testing (in guinea pigs) | No sensitization. |
| Biocompatibility requirements (general term, but specifically covered by the irritation and sensitization tests) | Biocompatibility requirements are met (as indicated by the animal studies). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the "test set" for each individual performance criterion. However, it indicates that testing was performed "as per ASTM D5250-06". This ASTM standard outlines specific sampling plans for various tests (e.g., water leak test for pinholes, physical dimensions, physical properties). Without access to the full test report or the specific ASTM D5250-06 standard, the precise sample size cannot be determined from the provided text.
The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer (Quantum Co., Ltd.) based in China. The study is retrospective in the sense that the testing was conducted on samples of the manufactured product to demonstrate compliance with existing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this device and study. The "ground truth" for the performance of examination gloves is established by objective, standardized laboratory tests (e.g., tensile strength machines, water leak testers, animal studies for biocompatibility), not by expert consensus or interpretations.
4. Adjudication method for the test set
This section is not applicable to this device and study. Adjudication methods (like 2+1, 3+1) are typically used in studies where subjective assessments by multiple human readers are involved (e.g., image interpretation). The performance of examination gloves is evaluated through objective physical and chemical tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable to this device and study. This device is a medical glove, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable to this device and study. This device is a physical product (medical glove), not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Objective, standardized physical and chemical measurements: These include tests for tensile strength, elongation, dimensions, freedom from holes (barrier integrity), and weight. These are defined within the ASTM D5250-06 standard.
- Biocompatibility testing: Animal models (rabbits for primary skin irritation and guinea pigs for delayed contact sensitization) were used to establish the "ground truth" regarding the absence of adverse biological reactions.
8. The sample size for the training set
This section is not applicable to this device and study. The concept of a "training set" is relevant for machine learning or AI models, which are not involved in the evaluation of this medical glove.
9. How the ground truth for the training set was established
This section is not applicable to this device and study, as there is no "training set" in the context of this product's evaluation.
§ 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.