(41 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.
Powder-free, Latex Patient Examination Glove with protein content labelling claim (50 ug/g glove or less).
This document is a 510(k) clearance letter from the FDA for a medical device, specifically a "Powder-Free, Latex Patient Examination Glove with protein content labelling claim (50 ug/g glove or less)."
The letter indicates that the device has been reviewed and found to be "substantially equivalent" to legally marketed predicate devices. This type of regulatory clearance does not necessarily involve a clinical study to prove performance against specific acceptance criteria in the way that a novel device might. Instead, it relies on demonstrating that the new device is as safe and effective as a device already on the market.
Therefore, for this specific submission:
- There is no explicit table of acceptance criteria and reported device performance as would be found for a new diagnostic or therapeutic device. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence to a predicate device, which would include performance benchmarks for characteristics like barrier integrity, tensile strength, and protein content. The "reported device performance" would be the results of the tests conducted by Kossan Latex Industries (M) Sdn. Bhd. to show that their glove meets these benchmarks. However, these specific test results are not detailed in the provided FDA letter.
- The document does not detail a specific "study" in the clinical trial sense for an AI device. The 510(k) process for a glove primarily focuses on performance testing (e.g., integrity and strength tests, protein content assays) against relevant standards and the predicate device.
Given the nature of a 510(k) for a patient examination glove, many of the requested fields are not applicable or the information is not present in the provided FDA clearance letter.
Here's how to address your request based on the provided document and general understanding of 510(k) approvals for such devices:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Latex Gloves) | Reported Device Performance (Not explicitly detailed in FDA letter, but assumed to meet criteria for clearance) |
|---|---|
| Protein Content: ≤ 50 micrograms/gram of glove | "with protein content labelling claim (50 ug/g glove or less)" - Device is designed to meet this claim. |
| Barrier Integrity (e.g., AQL for pinholes): Typically 1.5 - 4.0 | Assumed to meet relevant ASTM or ISO standards for medical gloves. |
| Physical Properties (e.g., Tensile Strength, Elongation): As per standard specifications | Assumed to meet relevant ASTM or ISO standards for medical gloves. |
| Biocompatibility: Non-toxic, non-irritating, non-sensitizing | Assumed to meet relevant ISO or FDA biocompatibility guidelines. |
| Sterility (if applicable): Sterile (if claimed) | Not claimed as sterile in this document. |
| Powder-Free: Must meet powder-free requirements | "Powder-Free" - Device is designed to meet this claim. |
Note: The FDA letter confirms the device is "substantially equivalent" to legally marketed predicate devices, which implicitly means it meets industry standards and performance benchmarks for patient examination gloves. The specific test results are part of the detailed 510(k) submission, not typically included in the public clearance letter.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided FDA letter. For physical and chemical tests of gloves, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., ISO 2859-1 for AQL sampling, ISO 37 for tensile properties).
- Data Provenance: Not specified, but the applicant is Kossan Latex Industries (M) Sdn. Bhd. from Malaysia. Testing would have been conducted by the manufacturer or a contracted lab. The data would be prospective, as it involves testing of the device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in the context of device performance testing for gloves. "Ground truth" in this context refers to standardized measurements (e.g., protein content via validated assays, physical properties via test machines). Clinical expert review is not generally used to establish performance for these types of physical/chemical properties.
4. Adjudication method for the test set
- Not applicable. Performance tests for gloves are typically objective measurements with predefined pass/fail criteria based on standards. There is no expert adjudication process for these types of tests.
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 device is a patient examination glove, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a patient examination glove, not an algorithm.
7. The type of ground truth used
- Objective Measurements/Standardized Assays: The "ground truth" for glove performance involves objective measurements of physical properties (tensile strength, elongation, barrier integrity via water leak tests) and chemical properties (extractable protein content via validated assays like modified Lowry or ELISA). Compliance with relevant ASTM or ISO standards serves as the benchmark.
8. The sample size for the training set
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is involved.
§ 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.