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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.

The device is a class I latex patient examination gloves 21 CFR 880.6250, Patient Examination Glove, LYY made by surface treatment on the inner and anti-tack coating on outer surface. The process modifies the surface characteristics that assist the user in donning the gloves with ease without the use of any dusting or donning powder is substantially equivalent in safety and effectiveness to the predicate device.

They are ambidextrous and come in different sizes, Extra Small, Small, Medium, Large and Extra Large.

The provided document is a 510(k) Premarket Notification for a Latex Examination Glove. It is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. This document does not describe an AI/ML-driven medical device. Therefore, it does not contain the information requested about acceptance criteria and a study proving an AI/ML device meets acceptance criteria.

The questions posed relate to the development and validation of an AI/ML device, which typically involves data sets, expert labeling, ground truth establishment, and performance metrics like sensitivity, specificity, or AUC. The provided text, however, focuses on:

• Physical properties of rubber gloves: Dimensions, tensile strength, elongation, freedom from holes, residual powder, and protein content.
• Biocompatibility testing: Skin irritation, dermal sensitization, and acute systemic toxicity.
• Comparison to a predicate device: Highlighting similarities in intended use, materials, and compliance with standards.

Since the document is for a physical medical product (gloves) and not an AI/ML device, I cannot extract the information required to answer your specific questions.

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