(55 days)
A patient examination glove is a disposable device intended for medical purposes that is donned by doctors and healthcare workers as protection against possible infection/contamination when examining a patient.
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This document is a 510(k) clearance letter from the FDA for "Hypoallergenic Latex Patient Exam Gloves." It explicitly states that the device is "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This type of clearance does not involve the detailed performance studies or statistical analyses typically required for novel medical devices. The FDA determines substantial equivalence primarily based on comparing the new device's technological characteristics and intended use to a legally marketed predicate device.
Therefore, the requested information regarding acceptance criteria, specific performance studies, sample sizes, expert involvement, and ground truth establishment is not available in this document and is not typically part of a 510(k) notification for devices like examination gloves.
Here's why and what can be inferred:
- Acceptance Criteria & Device Performance: For examination gloves, acceptance criteria relate more to material properties, physical dimensions, leak resistance, tensile strength, and biocompatibility, as defined by recognized standards (e.g., ASTM standards for medical gloves) that ensure they meet their intended protective function. The document confirms the device is a "patient examination glove" and is "hypoallergenic," implying it meets general performance standards for such devices and has been shown not to cause common allergic reactions associated with latex. However, specific numerical acceptance criteria and reported device performance (e.g., specific AQL levels for pinholes) are not detailed in this clearance letter.
- Study That Proves the Device Meets Acceptance Criteria: The "study" for a 510(k) of this nature typically involves demonstrating that the new device meets relevant consensus standards (like ASTM D3577 for rubber examination gloves) and that its hypoallergenic properties are substantiated, often through specific testing (e.g., protein content testing) compared to predicate devices. This isn't a clinical trial in the sense of comparing diagnostic accuracy or clinical outcomes.
- Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These concepts are relevant to software or AI-driven medical devices, or complex diagnostic/therapeutic devices that require extensive clinical validation. For a Class I device like an examination glove, these are generally not applicable. The equivalence is established by comparing technical specifications and performance against recognized standards or an existing predicate device.
- Data Provenance: Not applicable in the context of this device's clearance.
- Type of Ground Truth Used: For gloves, "ground truth" would be objective measurements against material specifications and safety standards (e.g., laboratory tests for protein content, leak resistance, physical dimensions).
- How Ground Truth for Training Set Was Established: Not applicable as a training set for machine learning is not used here.
In summary, this document is a regulatory clearance based on substantial equivalence, not a detailed performance study report. The questions posed are highly relevant for artificial intelligence/machine learning devices or those requiring extensive clinical studies, but not for a Class I device like examination gloves cleared via the 510(k) pathway.
§ 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.