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Powder free vinyl 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 Vinyl Patient Examination Gloves, Clear(non-colored)

The provided document describes the safety and effectiveness information for Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) submitted by SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD., under K092415.

Here's an analysis of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of typical AI/ML studies focusing on diagnostic accuracy. The performance data presented are based on adherence to established material and safety standards for medical gloves.

• Sample Size: Not explicitly stated for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). The claim is that the device "Meets" the specified standards, implying an adequate sample size was used to demonstrate compliance according to those standards.
• Data Provenance: The studies were conducted by the manufacturer, SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD., likely in China, as that is the submitter's country of origin. The studies are retrospective in the sense that they are engineering and biocompatibility tests conducted on manufactured product batches to ensure compliance with pre-defined standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and submission. This is a 510(k) submission for a Class I patient examination glove, which relies on demonstrating conformance to recognized consensus standards and biocompatibility tests, not on expert interpretations of medical images or clinical outcomes. The "ground truth" for these tests is defined by the objective metrics and methodologies outlined in the ASTM standards and FDA regulations (e.g., 21 CFR 800.20, ISO10993-10).

4. Adjudication method for the test set

This is not applicable. The "adjudication method" concept typically applies to studies where human experts are making subjective assessments that need to be reconciled (e.g., reading medical images). Here, the tests are objective measurements and evaluations against predefined criteria in standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers. This device is a medical glove, for which AI assistance for human readers is not applicable.

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

No, a standalone algorithm performance study was not done. This device is a physical product (a glove), not an algorithm or software. Therefore, this question is not relevant.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Standard Specifications: Adherence to the defined dimensional, physical, and powder residual limits set forth in ASTM standard D 5250-06 and D6124-06.
• Regulatory Requirements: Compliance with 21 CFR 800.20 for freedom from pinholes.
• Biocompatibility Test Results: Objective results from standardized animal tests (Primary Skin Irritation in rabbits, Dermal sensitization in guinea pig) showing "Passes" and "Not a Primary Skin Irritation" / "Not a Dermal Sensitization," as per ISO10993-10.

8. The sample size for the training set

The concept of a "training set" is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

This is not applicable, as there is no "training set" for this device.

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's performance against the acceptance criteria is demonstrated through a series of non-clinical tests. The summary explicitly states: "Powdered vinyl patient examination gloves, Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-06, per 21 CFR 800.20 and ISO10993-10." The table above details how the device meets each characteristic's standard.

Detailed Study Information:

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

   • The document does not specify the direct sample sizes for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility). It references standards (ASTM D5250-06, 21 CFR 800.20, ISO10993-10) which would typically define such sample sizes.
   • Data Provenance: The manufacturing company, SHIJIAZHUANG ELEGANCE PLASTIC PRODUCTS CO., LTD., is located in China. Therefore, it's highly probable the testing was conducted in China or by labs accredited to perform these tests for a Chinese manufacturer. The document does not explicitly state the country of origin of the data itself, only the submitter's address. The data is retrospective, as it refers to completed tests.

2. 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 question is not applicable to this type of device (patient examination gloves). The "ground truth" for these tests (e.g., whether a glove has pinholes, its tensile strength, or if it causes irritation) is determined by standardized laboratory methods and measurements, not by expert consensus or interpretation in the way medical image analysis might be.

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

   • Not applicable. Adjudication methods are typically associated with subjective assessments or classifications (e.g., in clinical trials or diagnostic studies), which is not the case for the objective physical and biocompatibility tests performed on these gloves.

4. 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 physical product (gloves), not an AI diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

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

   • Not applicable. This device is a physical product, not an algorithm.

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

   • The "ground truth" for this device type is established through objective, standardized laboratory measurements and compliance with industry and regulatory standards. For example:
     • Dimension, Physical Properties, Powder Amount: Measured against the specifications outlined in ASTM D 5250-06.
     • Freedom from pinholes: Determined by standardized water leak tests as per 21 CFR 800.20 (and often specified within ASTM standards as well).
     • Biocompatibility: Determined by standardized animal testing protocols (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) as per ISO 10993-10.

7. The sample size for the training set

   • Not applicable. This device is not an AI algorithm requiring a training set. The manufacturing process of physical products involves quality control, but not "training sets" in the AI sense.

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

   • Not applicable, as there is no training set for this type of device.

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