(90 days)
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.
§ 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.