(68 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
Safeskin Sterile Purple Nitrile Examination Gloves are sterile disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
Here's an analysis of the provided information, focusing on the acceptance criteria and study details for the Safeskin Sterile Purple Nitrile Examination Gloves:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Standard | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-99 | Meets ASTM D 6319-99 |
| Physical Properties | ASTM D 6319-99 | Meets ASTM D 6319-99 |
| Freedom from pinholes | ASTM D 6319-99 | Meets ASTM D 6319-99 |
| ASTM D 5151 | Meets ASTM D 5151 | |
| Powder-Free | ASTM D 6124 | Meets ASTM D 6124 |
| Powder-Free (quantitative) | 2 mg/glove maximum | Meets 2 mg/glove maximum |
| Primary Skin Irritation in Rabbits | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
Study Details
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report. Therefore, some of the requested information might not be explicitly detailed, especially concerning aspects typically found in clinical trials for more complex devices.
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Sample sizes used for the test set and the data provenance:
- The document does not explicitly state specific sample sizes used for testing each characteristic (e.g., number of gloves tested for dimensions, pinholes, etc.). It generally states that the device "meets" the respective ASTM standards.
- The provenance of the data (country of origin, retrospective/prospective) is not specified. However, the tests are laboratory-based conformance tests to established standards, not human clinical trials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in this context. The "ground truth" for examination gloves is defined by the objective, quantifiable parameters set forth in the ASTM standards (e.g., measurements, tensile strength, pinhole detection methods). Expert opinion is typically not used for these types of performance evaluations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where there's subjective interpretation (e.g., image reading). For objective performance testing against standards, the results are typically binary (pass/fail) based on direct measurement or observation.
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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 is not applicable. An MRMC study with AI assistance is relevant for diagnostic imaging devices where human interpretation is involved. This device is an examination glove, and its performance is assessed via physical and biological safety testing, not human reading of diagnostic output.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical product (examination glove), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is established by the specified objective criteria and test methods within the referenced ASTM standards (e.g., ASTM D 6319-99, ASTM D 5151, ASTM D 6124). For biocompatibility, it's based on standard animal model tests (rabbit skin irritation, guinea pig sensitization) designed to detect a biological response.
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The sample size for the training set:
- This information is not applicable. Training sets are used for machine learning algorithms. This device is a manufactured product requiring conformance testing to established hardware standards, not algorithmic training.
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How the ground truth for the training set was established:
- This information is not applicable, as there is no training set mentioned or implied for this type of device.
Overall Conclusion from the Provided Document:
The device, Safeskin Sterile Purple Nitrile Examination Gloves, meets the acceptance criteria by demonstrating conformance to established industry standards (ASTM D 6319-99, D 5151, D 6124) for dimensions, physical properties, freedom from pinholes, and powder content. Additionally, it passed biocompatibility tests (primary skin irritation in rabbits and guinea pig sensitization). The study demonstrating this is primarily a series of laboratory-based conformance tests against these published standards. Clinical data was deemed not necessary for this type of disposable medical glove. The FDA's 510(k) clearance signifies that the device is substantially equivalent to a legally marketed predicate device based on these performance characteristics.
§ 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.