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A 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. This device is for single use only.

Biodegradable Thermoplastic Elastomer Examination (TPE) Glove

This document is a 510(k) clearance letter for a Biodegradable Thermoplastic Elastomer Examination (TPE) Glove. It is not anAI/ML device. Therefore, a study demonstrating device performance against acceptance criteria in the manner described in the request is not applicable.

The 510(k) clearance process for a glove like this primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different technological characteristics but does not raise different questions of safety and effectiveness and is as safe and effective as the legally marketed device.

The information provided (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, training set details) are typically relevant for AI/ML-driven medical devices that require performance evaluation against a defined ground truth for diagnostic accuracy, sensitivity, specificity, etc. This is not the case for a patient examination glove.

For this device, acceptance criteria would typically revolve around:

• Physical Properties: Tensile strength, elongation before break, puncture resistance, freedom from pinholes (water leak test).
• Biocompatibility: Absence of irritation, sensitization, or cytotoxicity (e.g., ISO 10993 standards).
• Sterility (if applicable): Assurance of an appropriate sterility assurance level (SAL).
• Dimensions: Conformance to industry standards for glove sizing.
• Indication for Use: Clearly stating the intended purpose (e.g., "to prevent contamination between patient and examiner").

The "study" proving it meets acceptance criteria would be a series of physical, chemical, and biological tests conducted according to recognized standards (e.g., ASTM, ISO) comparing the new glove's performance to the predicate device and relevant industry standards for examination gloves.

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