(248 days)
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.
Classified by FDA's general and Plastic device Panel as Class I (21 CFR 880.6250), NIPROTECT Powder-free Nitrile Ambidextrous Gloves (80LZA). Meets all requirements of ASTM D6319 Standard for Nitrile Examination gloves for medical application.
The provided document is a 510(k) summary for the NIPROTECT Powder-Free Nitrile Ambidextrous Gloves, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets acceptance criteria in the same way a new, novel AI/software medical device would.
Therefore, many of the requested categories for AI/software medical device studies either do not apply or cannot be extracted directly from this document. However, I can extract the acceptance criteria as described for this glove and how the manufacturer states it meets them.
Here's a breakdown based on the provided text, with explanations for the categories that are not applicable:
- Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 6319 Standard for Nitrile Examination gloves for medical application | Meets ASTM D 6319 |
| Physical Properties | Meets ASTM D 6319 Standard for Nitrile Examination gloves for medical application | Meets ASTM D 6319 |
| Tensile Strength (minimum) | Meets ASTM D 412 | Meets ASTM D 412 |
| Freedom from holes | Meets ASTM D 6319 Standard for Nitrile Examination gloves for medical application AND Meets ASTM D 5151 | Meets ASTM D 6319 and Meets ASTM D 5151 |
| Powder Free | Meets ASTM D 6319 Standard for Nitrile Examination gloves for medical application AND Meets ASTM D 6124 | Meets ASTM D 6319 and Meets ASTM D 6124 |
| Puncture | Meets EN 388 | Meets EN 388 |
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. For physical device testing against ASTM standards, specific sample sizes and testing methodologies are defined within those standards, but the summary does not detail the actual sample sizes used by the manufacturer. The data provenance would typically be from the manufacturer's testing facilities (MAPA PROFESSIONAL).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable to a physical device like a glove being tested against engineering standards. "Ground truth" in this context is defined by the objective measurements outlined in the ASTM and EN standards (e.g., measuring tensile strength, checking for holes).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable to a physical device being tested against engineering standards. Testing against standards involves predefined procedures and measurement instruments, not human adjudication of subjective assessments.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This concept is not applicable as this is a physical medical device (examination gloves), not an AI/software medical device for interpretation or diagnosis.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This concept is not applicable as this is a physical medical device (examination gloves), not an AI/software medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by objective measurements and procedures defined within widely accepted engineering standards (ASTM D6319, ASTM D412, ASTM D5151, ASTM D6124, EN 388). These standards detail how to measure dimensions, physical properties, tensile strength, freedom from holes, powder content, and puncture resistance.
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The sample size for the training set
- This concept is not applicable as this is a physical medical device, not an AI/software medical device that undergoes "training."
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How the ground truth for the training set was established
- This concept is not applicable as this is a physical medical device and does not involve a "training set" or AI model.
§ 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.