(453 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand or finger to prevent contamination between patient and examiner.
Powder Free Latex Examination Glove
This appears to be an FDA 510(k) clearance letter for a Class I medical device, specifically "Powder Free Latex Examination Gloves." This type of clearance focuses on demonstrating substantial equivalence to a predicate device, primarily through established performance standards and manufacturing controls, rather than extensive clinical study data.
Therefore, the document does not contain the information requested regarding acceptance criteria and studies proving the device meets those criteria, as typically seen for higher-risk devices or AI/software-as-a-medical-device (SaMD) products.
Here's why and what kind of information would typically be needed for the questions you've asked, if this were a different type of device:
- For a Class I device like examination gloves: The "acceptance criteria" primarily relate to national/international standards for glove performance (e.g., ASTM standards for barrier integrity, dimensions, tensile strength, protein content for latex gloves). The "study" proving this would involve laboratory testing against these standards, typically performed by the manufacturer and submitted to the FDA as part of their 510(k) application to demonstrate conformance. The provided document is the outcome of that review, not the detailed submission itself.
If this were a more complex device (e.g., an AI/SaMD product), the requested information would look like this:
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Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Would typically define specific thresholds for performance metrics (e.g., sensitivity ≥ 90%, specificity ≥ 85%, AUC ≥ 0.90, average reading time reduction ≥ X seconds). These would often be based on clinical need, predicate device performance, or stakeholder input.
- Reported Device Performance: Would present the actual values achieved by the device in predefined test sets for those metrics, along with confidence intervals.
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Sample size used for the test set and data provenance:
- Sample Size: A specific number of cases/patients (e.g., 500 cases).
- Data Provenance: Details like "retrospective, multi-center data from 3 hospitals in the USA and 2 in Europe" or "prospectively collected data from a single academic institution in Japan."
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Number of experts used to establish the ground truth for the test set and qualifications:
- Number of Experts: E.g., "3 experts."
- Qualifications: "Board-certified radiologists, each with over 10 years of experience in chest imaging, including sub-specialization in oncology."
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Adjudication method for the test set:
- Method: E.g., "2+1 consensus (if two experts agreed, that was the ground truth; if they disagreed, a third expert resolved the discrepancy)" or "majority vote among 3 readers."
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Multi-reader multi-case (MRMC) comparative effectiveness study:
- Yes/No: Explicitly state if one was done.
- Effect Size: "Readers improved their AUC by an average of 0.05 (from 0.85 to 0.90) with AI assistance, a statistically significant improvement (p
§ 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.