(31 days)
QTEXX Powder free Latex Examination Glove, polymer-coated 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, Polymer-coated meet the current specification 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 is related to a 510(k) submission for QTEXX Powder Free Latex Examination Gloves. This device is a medical glove, and the acceptance criteria and study design described are for demonstrating its physical and biocompatibility properties, rather than diagnostic performance metrics typically associated with AI/ML devices. As such, many of the requested fields (e.g., effect size of human readers, training set details) are not applicable.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D 3578-95, Standard Specification for Rubber Examination Gloves | QTEXX Powder Free Latex Examination Gloves meet all the current specifications listed under ASTM D 3578-95. |
| 21 CFR 800.20 (Quality System Regulation for Medical Devices) | Gloves meet all current specifications listed under ASTM D 3578-95 and 21 CFR 800.20. |
| Primary skin irritation (rabbit) | Indicates no irritation. |
| Delayed contact sensitization (guinea pig) | Indicates no sensitization. |
| Presence of starch (USP iodine test) | Final product is negative for the presence of starch. |
| Total Water Extractable Protein (for protein label claim) | 50 micrograms or less of Total Water Extractable Protein per gram. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test performed under ASTM D 3578-95 or for the biocompatibility tests (skin irritation, sensitization). However, the tests are performed on the device itself.
- Data Provenance: The tests were conducted by the manufacturer, Latexx Partners Berhad, based in Malaysia. The testing is non-clinical/bench testing and animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical medical glove and not an AI/ML imaging device that requires expert ground truth for diagnostic accuracy. The "ground truth" for these tests comes from established international standards (ASTM) and regulatory requirements (21 CFR). Biocompatibility tests are performed on animals.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against established physical and chemical standards, and animal responses to the material. No human adjudication of diagnostic output is involved.
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
Not applicable. This is not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used
The ground truth used for this device's performance validation is a combination of:
- Standard Specifications: ASTM (American Society for Testing and Materials) D 3578-95 for physical properties (e.g., tensile strength, elongation, barrier integrity).
- Regulatory Requirements: 21 CFR 800.20 for general medical device quality.
- Biocompatibility Testing: In vivo animal studies (rabbits for skin irritation, guinea pigs for sensitization) for biological safety.
- Chemical Testing: USP iodine test for starch presence, and methods for determining total water extractable protein.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of 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.