(291 days)
A patient examination Powder Free Nitrile Blue Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
POWDER FREE NITRILE BLUE EXAMINATION GLOVE
This document is a 510(k) clearance letter for a "Powder Free Nitrile Blue Examination Glove." It does not contain information about acceptance criteria or a study proving device performance as typically expected for advanced medical devices with complex algorithms.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. Substantial equivalence for examination gloves is primarily based on meeting recognized consensus standards for physical properties and barrier integrity.
Therefore, many of the requested details about acceptance criteria and study methodology are not applicable to this type of device and document.
However, based on the nature of examination gloves, we can infer some general acceptance criteria and the type of testing usually performed to demonstrate substantial equivalence, even if the specific study details are not in this letter.
Here's an attempt to answer your questions by inferring common requirements for examination gloves where the document doesn't explicitly state them:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance in the manner of a clinical study or performance report for an AI/algorithm-based device. For examination gloves, acceptance criteria are typically defined by recognized consensus standards (e.g., ASTM D6319 for Nitrile Examination Gloves). These standards cover properties such as:
| Acceptance Criteria (Inferred from ASTM D6319 for Nitrile Gloves) | Reported Device Performance (Not explicitly in this document, but implied by 510(k) clearance) |
|---|---|
| Physical Properties (before aging): | (Implied to meet or exceed standard requirements) |
| Tensile Strength (MPa) | (e.g., >14 MPa, typical) |
| Elongation at Break (%) | (e.g., >500%, typical) |
| Physical Properties (after accelerated aging): | (Implied to meet or exceed standard requirements) |
| Tensile Strength (MPa) | (e.g., >14 MPa, typical, with specific % retention) |
| Elongation at Break (%) | (e.g., >400%, typical, with specific % retention) |
| Barrier Integrity (Water Leak Test): | (Implied to meet standard Acceptable Quality Limit (AQL)) |
| Acceptable Quality Limit (AQL) for pinholes | (e.g., AQL 2.5%, maximum 2.5% failure rate for water leak test per lot) |
| Biocompatibility: | (Implied to be biocompatible, typically tested per ISO 10993) |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation | Non-irritating |
| Other (e.g., Dimensions, Powder Residue): | (Implied to meet standard requirements) |
2. 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 510(k) letter. Testing for examination gloves to a consensus standard generally involves a sampling plan from production lots. The specific sample sizes would be defined by the relevant ASTM or ISO standards (e.g., for AQL testing). The device is manufactured by Liwe Trading in Malaysia, suggesting the testing data would originate from Malaysia or a contract lab. The testing is typically prospective for each new lot/design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to examination gloves. "Ground truth" in the context of expert consensus is relevant for diagnostic devices that interpret signals or images. For gloves, performance is measured against objective physical and chemical properties using standardized test methods, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for examination gloves. Performance is measured objectively through lab tests, not by human adjudication of complex findings.
5. 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 for an examination glove, not an AI/algorithm-based diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is for an examination glove.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For examination gloves, the "ground truth" for performance is defined by adherence to objective physical, chemical, and barrier integrity criteria established in recognized consensus standards (e.g., ASTM, ISO). These are determined through laboratory testing (e.g., tensile strength testing, water leak tests, biocompatibility assays), not expert consensus in the diagnostic sense.
8. The sample size for the training set
Not applicable. Examination gloves are not AI/machine learning devices that require training sets. Their performance is inherent in their design and manufacturing process, validated through physical testing.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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.