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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

This FDA 510(k) clearance letter pertains to Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color. As such, the "device" is essentially a commodity, and the provided document is a regulatory approval, not a scientific study report. Therefore, most of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment is not present or applicable in this context.

However, I can extract information related to the device description and the regulatory context.

• Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves With Aloe Vera, Green Color
• Regulation Number: 880.6250
• Regulation Name: Patient Examination Gloves
• Regulatory Class: I
• Product Code: LYZ

Since this is a clearance for examination gloves, the "acceptance criteria" generally refer to meeting established performance standards for medical gloves, which are typically defined by organizations like ASTM International. The study to prove these criteria would involve standardized physical and chemical testing. The document does not detail these specific tests or their results.

Here's how I can address the prompts based on the available information, with explanations for what cannot be found:

1. A table of acceptance criteria and the reported device performance

Explanation: The letter does not describe specific acceptance criteria or performance data. For examination gloves, these criteria would typically include tests for tensile strength, elongation, barrier integrity (e.g., freedom from holes), biocompatibility (e.g., skin irritation, sensitization), and powder content as per relevant ASTM standards (e.g., ASTM D5250 for vinyl examination gloves). The "reported device performance" would be the results of these tests, which are not detailed in this regulatory letter.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information Not Present: The document does not specify sample sizes for testing or data provenance.
Likely Context: For medical gloves, sample sizes for performance tests are generally determined by international standards (e.g., ISO 2859-1 for sampling procedures) or specific test methods. The data would originate from laboratory testing of glove batches, likely conducted by the manufacturer (Shanghai PM Plastics Enterprise Company Limited) in China, as that is the company's location. These would be prospective tests on manufactured samples.

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)

Information Not Applicable/Present: For a commodity device like examination gloves, "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus on a diagnosis) is not applicable. The "ground truth" for glove performance is established by standardized, objective laboratory tests. The "experts" involved would be technicians performing these tests and engineers/quality control personnel interpreting the results against established standards. Their qualifications would be in laboratory testing, material science, or quality assurance, not clinical diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information Not Applicable/Present: Adjudication methods like 2+1 or 3+1 are typically used in clinical or imaging studies where subjective interpretation is involved. For standardized physical testing of examination gloves, adjudication in this sense is not employed. Test results are objective measurements (e.g., force to break, number of pinholes) and are compared directly to numerical specifications. Quality control processes would involve reviewing test reports and ensuring compliance with specifications.

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

Information Not Applicable: This is an approval for a physical medical device (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is entirely irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Information Not Applicable: As noted above, this is not an AI-powered device. Therefore, no standalone algorithm performance study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" for examination gloves is based on objective, standardized laboratory measurements of physical properties (e.g., tensile strength, elongation, barrier integrity) and chemical characteristics (e.g., powder content, biocompatibility) as defined by applicable consensus standards (e.g., ASTM standards for medical gloves). It is not expert consensus on an image, pathology, or outcomes data.

8. The sample size for the training set

Information Not Applicable/Present: For a physical medical device like examination gloves, there isn't a "training set" in the context of machine learning. The manufacturing process is controlled by Good Manufacturing Practices (GMPs) and quality systems, where process parameter adjustments are made based on ongoing quality control feedback and engineering principles, not a distinct "training set" of data for an algorithm.

9. How the ground truth for the training set was established

Information Not Applicable: As there is no "training set" in the machine learning sense, the concept of establishing ground truth for it is not applicable. The "ground truth" for the performance of examination gloves is established by adherence to specified performance dimensions in recognized standards, which are met through controlled manufacturing and quality assurance testing.

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