(67 days)
QTEXX, Non - Chlorinated Powder free Nitrile 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, Non - Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-coated meet the current specification listed under the ASTM Specification D 3578 – 99, Standard Specification for Rubber Examination Gloves, They are blue or natural white in colour and are powder free.
Here's a breakdown of the acceptance criteria and study information for the QTEXX Non-Chlorinated, Powder Free Nitrile Examination Gloves, Polymer-Coated, based on the provided document:
This document is a 510(k) submission for a medical device (nitrile examination gloves) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study report with specific acceptance criteria and performance metrics for an AI/algorithm-driven device.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, direct effect sizes for AI improvement) are not applicable to this type of regulatory submission for a physical medical glove. The "device" in this context is the glove itself, not an AI or software algorithm.
However, I can extract the relevant information regarding performance criteria and the studies conducted to meet them as presented in the document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (based on ASTM D 3578-99 and 21 CFR 800.20) | Reported Device Performance | Study Type |
|---|---|---|---|
| Physical Properties | Meets all current specifications listed under ASTM Specification D 3578-99, Standard Specification for Rubber Examination Gloves for Medical Applications. | Gloves meet all current specifications listed under ASTM D 3578-99. | Nonclinical Testing |
| Biocompatibility | No irritation in primary skin irritation testing in rabbits. | Indicate no irritation. | Nonclinical Testing (Animal Study) |
| No sensitization in delayed contact sensitization testing in guinea pigs. | Indicate no sensitization. | Nonclinical Testing (Animal Study) | |
| Powder-Free Status | Negative for the presence of starch using the USP iodine test. | Negative for the presence of starch. | Nonclinical Testing |
Note: The document states that the device is "substantially equivalent to the Class 1 patient examination glove 80LZA. It meets all the current specifications listed under the ASTM Specification D 3578 – 99, Standard Specification for Rubber Examination Gloves". The table above extracts the implicit and explicit criteria mentioned.
Study Details (as applicable to a physical medical device)
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Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for the nonclinical tests (e.g., how many gloves were tested for physical properties, how many rabbits/guinea pigs were used). This level of detail is typically found in the full study reports, not the summary K992924 submission.
- Data Provenance: The origin of the data is from testing conducted by the manufacturer, Latexx Partners Berhad, likely in Malaysia, to meet U.S. regulatory standards (ASTM and FDA). This would be considered prospective testing specifically for this device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This question typically pertains to studies involving human interpretation (e.g., medical imaging, clinical assessments) where expert consensus establishes a "ground truth" for an algorithm. For physical device testing like gloves, "ground truth" is established by standard laboratory measurements and observations against predefined criteria.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is for clinical interpretation studies. Laboratory testing results are typically directly measured and compared to specifications.
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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. No MRMC study was conducted or is relevant for this physical device. This question applies to AI-assisted diagnostic or interpretive tasks.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not Applicable. This applies to AI/software performance. The performance described here is for the physical glove itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Objective Measurement against Standards: The "ground truth" for the physical properties of the gloves (e.g., dimensions, tensile strength, freedom from holes) is defined by the ASTM D 3578-99 standard specifications.
- Observed Biological Response: For biocompatibility, the "ground truth" is the observed biological response (lack of irritation or sensitization) in the animal models, as per established toxicology testing protocols.
- Chemical Reaction: For powder-free status, the "ground truth" is the absence of a positive chemical reaction (USP iodine test).
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The sample size for the training set:
- Not Applicable. This question refers to machine learning algorithms. The manufacturing process of the gloves might involve internal quality control data, but there is no "training set" in the AI sense for establishing the glove's core performance.
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How the ground truth for the training set was established:
- Not Applicable. As per point 7.
§ 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.