(42 days)
The True Advantage Non-Sterile Powder Free Purple Nitrile Patient Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).
Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile Properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile Rubber is known to create a barrier to bloodborne pathogens and and body fluids. ASTM D6319 conforming tensile properties create a glove that Is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D6319-00 and ASTM D5151-99 requirements.
Here is a summary of the acceptance criteria and the study details for the device, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Performance Standard/Specification | Acceptance Criteria (Stated) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Synthetic inner coating | Proposed | Synthetic inner coating with no starch donning powder added and with a purple color claim |
| Starch donning powder | Proposed | No starch donning powder added |
| Color claim | Purple | Purple |
| Water Tightness | ASTM D5151-99 & 1988 FDA 1000 mL Water Test | PASSES |
| Antigenic Protein | ASTM D6499-00 | PASSES |
| Safety (Guinea Pig Sensitization) | (Implied: Acceptable safety based on predicate performance) | PASSES |
| Safety (Rabbit Irritation) | (Implied: Acceptable safety based on predicate performance) | PASSES |
| General Performance Characteristics | ASTM D6319-00a & ASTM D3578-88 (Tensile properties, etc.) | (Implied: meets or exceeds acceptable scores for the predicate product) |
Study Details:
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Sample sizes used for the test set and the data provenance: Not explicitly stated. The document refers to "data summaries" and general conformance to ASTM standards, but does not provide specific sample sizes for tests like water tightness, antigenic protein, guinea pig sensitization, or rabbit irritation. The data provenance is not specified beyond being generated by Tillotson Healthcare Corporation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study focuses on objective performance testing of a physical product (examination gloves) against established ASTM and FDA standards, not an assessment requiring expert interpretation of results for ground truth establishment.
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Adjudication method for the test set: Not applicable. The tests are objective measurements against defined standards, not requiring human adjudication.
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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: Not applicable. This is a medical device (examination glove) without an AI component or a human-in-the-loop performance aspect.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- Objective Performance Standards: The ground truth for performance was established by recognized industry standards (ASTM D6319-00a, ASTM D3578-88, ASTM D5151-99, ASTM D6499-00) and an FDA water test (1988 FDA 1000 mL Water Test).
- Predicate Device Equivalence: Safety and effectiveness "equalt to or greater than" the legally marketed predicate device (Pilgram Nitrile Latex Examination Glove K905765A) was used as a comparative benchmark.
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The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable. No training set was used.
§ 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.