(23 days)
QTEXX Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
QTEXX Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.
The provided text describes the acceptance criteria and the study for "QTEXX POWDER FREE LATEX EXAMINATION GLOVES". Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM D 3578-95) | Reported Device Performance |
|---|---|
| Meets "Standard Specification for Rubber Examination Gloves" | "Gloves meet all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves." |
| Not Specified (Primary Skin Irritation) | "Primary skin irritation testing in the rabbit... indicate no irritation" |
| Not Specified (Delayed Contact Sensitization) | "delayed contact sensitization testing in the guinea pig indicate... no sensitization." |
| Not Specified (Presence of Starch) | "Final product is negative for the test for presence of starch using the USP iodine test." |
| Total Water Extractable Protein | "with 50 Micrograms or Less of Total Water Extractable Protein Per Gram" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test within ASTM D 3578-95 or for the biocompatibility tests (skin irritation, sensitization). It states that "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20", which implies the manufacturer followed the sampling guidelines stipulated in those standards.
- Data Provenance: The document states "Nonclinical laboratory and animal data indicate that the powder free product meets all performance and biocompatibility requirements." This indicates that the testing was conducted in a laboratory setting (likely by the manufacturer or a contracted lab) and involved animal models. The country of origin for the data is not explicitly stated but can be inferred as Malaysia, where the manufacturer is located. The tests are prospective as they were conducted to demonstrate compliance for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable in the context of device performance testing for examination gloves. The "ground truth" for these types of devices is established by objective measurements against established engineering and material standards (ASTM D 3578-95) and regulatory requirements (21 CFR 800.20, biocompatibility guidelines). There are no human expert interpretations required for parameters like glove dimensions, tensile strength, or protein content.
4. Adjudication Method for the Test Set
This is not applicable for this type of device testing. Adjudication methods (like 2+1, 3+1) are typically used for studies involving subjective interpretations, such as medical image analysis, where multiple experts might disagree. For physical device performance, the results are objective measurements.
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 is not applicable. This device is a latex examination glove, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of "human readers improving with AI" are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This device is not an algorithm or software. It is a physical medical device (examination glove).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is based on objective, verifiable standards and laboratory measurements:
- ASTM D 3578-95: This standard defines the physical and performance requirements for rubber examination gloves (e.g., dimensions, tensile strength, elongation, watertightness).
- Biocompatibility Testing: Standards for primary skin irritation (e.g., ISO 10993-10) and sensitization (e.g., ISO 10993-10) using animal models, which involve objective assessment of tissue reactions.
- Chemical Testing: USP iodine test for starch and an unspecified method for total water extractable protein.
8. The Sample Size for the Training Set
This is not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This 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.