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A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powdered Nitrile Blue Examination Gloves

The provided text is a 510(k) premarket notification letter from the FDA for Powdered Nitrile Blue Examination Gloves. This document is for a medical device that falls under Class I (general controls) and is determined to be substantially equivalent to existing predicate devices.

Crucially, this type of FDA document for a Class I general control device like examination gloves does NOT contain the kind of detailed clinical study information requested in your prompt.

The questions you've asked (about acceptance criteria, specific study designs like MRMC, sample sizes, ground truth establishment, expert qualifications, etc.) are typically associated with higher-risk medical devices (Class II with Special Controls or Class III PMA devices) that require more robust clinical evidence to demonstrate safety and effectiveness.

For Class I devices like examination gloves, "acceptance criteria" primarily relate to performance standards (e.g., tear resistance, barrier integrity, biocompatibility, dimensions) which are usually met through bench testing and adherence to recognized consensus standards (like ASTM standards for medical gloves) during manufacturing. The "study" proving these criteria are met would be these bench tests, not clinical trials in the way you're describing.

Therefore, I cannot provide answers to your specific questions based on the provided document. The document confirms the device's classification, its intended use, and its substantial equivalence to a predicate, but does not detail a clinical study with elements like expert adjudication or MRMC analysis.

However, if we were to infer what "acceptance criteria" and "study" would look like for such a device, it would generally involve:

• Acceptance Criteria (hypothetical, based on common glove standards):
  • Barrier Integrity (e.g., AQL for pinholes): A certain Acceptable Quality Level (AQL) for pinholes (e.g., 2.5% for general purpose, 1.5% for surgical)
  • Tensile Strength & Elongation: Meeting minimum breaking strength and elongation percentages before break.
  • Dimensions: Conforming to specified length, palm width, and finger thickness.
  • Powder Residue (if powdered): Below a specified limit (though this device is "Powdered Nitrile Blue" meaning it likely contains powder, but standards might set a max acceptable level or require specific labeling).
  • Biocompatibility: Non-irritating, non-sensitizing (tested via ISO 10993 standards).
  • Freedom from hazardous substances: Compliance with relevant regulations for restricted substances.
• "Study" to prove criteria conformance (hypothetical):
  • Bench Testing: Lot-by-lot or sampling-based testing for AQL (water leak test for pinholes), tensile properties, dimensions, and powder content.
  • Biocompatibility Testing: In vitro or in vivo tests (e.g., cytotoxicity, irritation, sensitization assays) to ISO 10993 standards.

None of these details, however, are present in the provided FDA letter.

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A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powder Free Examination Glove

The provided document is a 510(k) clearance letter from the FDA for a Nitrile Blue Powder Free Examination Glove. This document does not contain information about acceptance criteria or a study proving that an AI device meets these criteria. The approval is for a physical medical device (examination glove), not an AI-powered diagnostic or therapeutic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, expert qualifications, or AI-related metrics like MRMC studies or standalone AI performance.

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Latex examination powderfree gloves are worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient.

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This document is a 510(k) premarket notification from the FDA for medical gloves. It does not contain any information about acceptance criteria or a study that proves a device meets those criteria for software or AI-based medical devices.

The provided text pertains to a traditional medical device (latex examination gloves) and the FDA's substantial equivalence determination for its marketing. Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document.

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Latex Examination powdered glove is a disposable device intended for Medical purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.

Latex Examination Powdered Gloves

I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for "Latex Examination Powdered Gloves," indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.

The document discusses the regulatory classification, general controls, and market authorization for the gloves. It also includes an "Indications for Use Statement" for the product. However, it does not contain any details about performance metrics, study designs, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Therefore, I cannot provide the requested information in the specified format.

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