(4 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E, and protein claim (50 micrograms or less).
The provided 510(k) summary for the "Non-sterile, powder-free latex examination gloves with polymer coating, aloe, vitamin E and protein claim (50 micrograms or less)" does not contain a study to prove the device meets specific acceptance criteria in the manner of a typical clinical performance study for an AI/ML device or diagnostic tool. Instead, this submission is an Abbreviated 510(k) based on substantial equivalence to a predicate device (Siam Sempermed Latex Patient Examination Glove, Powder free, 510(k) #K970794).
The acceptance criteria here are primarily regulatory and performance characteristics being compared to the predicate device, demonstrating that the new device is as safe and effective as the previously cleared one.
However, I can extract the information requested based on the context of a 510(k) submission for a medical glove.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating "substantial equivalence" to a predicate device. This involves comparing technological characteristics and showing that the new device is as safe and effective. The reported device performance is implicitly that it meets or is comparable to the predicate device across various parameters.
| Acceptance Criteria Category | Specific Criteria/Comparison to Predicate | Reported Device Performance |
|---|---|---|
| General Characteristics | Substantially Equivalent to predicate device (K970794) | Device is substantially equivalent to K970794 |
| Indications for Use | Identical to predicate device | Identical |
| Target Population | Identical to predicate device | Identical |
| Design | Similar to predicate device | Similar |
| Materials | Similar to predicate device (Latex, polymer coating, aloe, vitamin E) | Similar |
| Performance | Identical to predicate device (e.g., barrier integrity, physical properties) | Identical (Specific performance data would be in the "additional technical comparative table" mentioned as "attached in the main submission" but not provided here.) |
| Sterility | Identical to predicate device (Non-sterile) | Identical |
| Biocompatibility | Identical to predicate device | Identical |
| Mechanical Safety | Identical to predicate device | Identical |
| Chemical Safety | Identical to predicate device | Identical |
| Anatomical Sites | Identical to predicate device (Worn on examiner's hand) | Identical |
| Human Factors | Identical to predicate device | Identical |
| Protein Claim | Protein content ≤ 50 micrograms (as implied by device name) | Implied to meet this claim (specific measurement data not in summary) |
| Standards Met | Identical to predicate device (e.g., ASTM standards for medical gloves) | Identical (Specific standards not listed in the summary, but presumed to be met as part of "Performance" and "Mechanical/Chemical Safety".) |
Study Details (as applicable for a 510(k) of a medical glove)
Given that this is a 510(k) for a medical glove based on substantial equivalence, the "study" referred to generally involves a comparison of technical characteristics and performance testing rather than a clinical trial with experts establishing ground truth in the way of an AI/ML diagnostic.
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Sample size used for the test set and the data provenance:
- The provided summary does not detail specific sample sizes for performance tests (e.g., tensile strength, puncture resistance, protein content). Such data would typically be found in the "additional technical comparative table" mentioned but not included in this extract.
- Provenance: Not explicitly stated, but typically these tests are conducted internally by the manufacturer (Siam Sempermed Corp., Ltd.) during product development and quality control.
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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 in the sense of clinical ground truth. For a medical glove, "ground truth" relates to objective physical, chemical, and biological properties (e.g., dimensions, barrier integrity, protein content, biocompatibility). These are established through standardized testing procedures, not by human expert interpretation.
- The experts involved would be quality engineers, chemists, and microbiologists conducting the tests, often overseen by qualified staff (e.g., Dr. Poonsuk Cherdkiatgumchai, Chief Quality Officer).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in interpreting complex clinical data (e.g., radiology reads). For a physical device like a glove, test results are typically objective measurements against engineering specifications or established standards (e.g., ASTM).
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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. This device is a medical glove, not an AI/ML diagnostic tool. There are no "human readers" to assist in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical glove, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for a medical glove refers to its objective, measurable physical, chemical, and biological properties as defined by relevant standards (e.g., ASTM D3577 for examination gloves, ISO 10993 for biocompatibility) and regulatory requirements (e.g., protein content limits).
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The sample size for the training set:
- Not applicable. This device is a physical product, not an AI/ML model that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set is used 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.