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A 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 EXAM GLOVES WITH ALOE COATING INSIDE

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for "Powder-Free Vinyl Examination Gloves with Aloe Coating Inside."

The letter primarily focuses on:

• Substantial Equivalence Determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Classification: Identifying the device as Class I and subject to general controls.
• Compliance with Regulations: Reminding the manufacturer of their responsibility to comply with various FDA regulations (e.g., registration, listing, labeling, good manufacturing practices).
• Indications for Use Statement: Defining the intended use of the glove.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Types of ground truth used.
• Sample size for training sets or how ground truth for training was established.

This type of FDA clearance (510(k)) typically relies on demonstrating substantial equivalence to a predicate device, often through performance testing detailed in the submission, but the letter itself does not contain the specifics of those tests or their results.

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A 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 EXAMINATION GLOVES

The provided document is a 510(k) premarket notification letter from the FDA to General Gloves Corporation regarding "Powder Free Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

It primarily serves as:

• A confirmation of the FDA's review and their determination of substantial equivalence for the device to legally marketed predicate devices.
• An authorization for General Gloves Corporation to market the device, subject to general controls of the Act.
• A reminder of the company's responsibilities under various FDA regulations.
• A statement of Indications for Use for the device.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document. The document is a regulatory approval letter, not a detailed study report.

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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.

Class 1 vinyl patient examination glove 80LYZ, powdered, that meets all the requirements of ASTM D 5250 - 92.

This document (K992107) describes a submission for "GG" vinyl examination gloves, powder-free, from General Gloves Corp. It is a 510(k) summary, which indicates it's for claiming substantial equivalence to a legally marketed device rather than a de novo approval requiring extensive clinical trials.

Therefore, the document does not contain information about a study proving the device meets acceptance criteria in the way one would expect for a novel medical device like an AI-powered diagnostic tool. Instead, it demonstrates compliance with a recognized standard and compares the device's characteristics to a predicate device.

Here's an analysis based on the provided text, addressing your points where applicable, and noting when the information is not present in this type of submission:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are generally derived from the ASTM D 5250 - 92 standard for patient examination gloves. The reported device performance is stated to meet or exceed these standards.

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

The document mentions "inspection level S-2, AQL 4.0" for dimension/tolerance and physical requirements. These are sampling plans from standards, but the exact sample size (number of gloves tested from a batch) is not explicitly stated in the summary, as it depends on the lot size.

The data provenance is from Taiwan (Tung Chung Village, Tung Shan Hsian, Tainan Hsien, Taiwan, R.O.C.), where General Gloves Corp. is located. The tests would be considered prospective manufacturing quality control tests.

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 and not provided for this type of device submission. Glove testing relies on standardized physical and chemical tests, not expert interpretation of outputs.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically associated with subjective assessments or diagnostic studies. Glove testing involves objective measurements based on established 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

This information is not applicable. This is a submission for an examination glove, not an AI-powered diagnostic device.

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

This information is not applicable. This is a submission for an examination glove, not an algorithm.

7. The type of ground truth used

The "ground truth" here is compliance with the ASTM D 5250 - 92 standard for patient examination gloves and FDA pinhole requirements. This is based on objective, quantifiable physical and chemical properties of the gloves.

8. The sample size for the training set

This information is not applicable. This is a physical product (glove), not a machine learning algorithm that requires a training set.

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

This information is not applicable. As above, it's not an AI/ML device requiring a training set. The "ground truth" for glove quality is established by adherence to a recognized international standard (ASTM D 5250 - 92).

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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.

Class 1 vinyl patient examination glove 80LYZ, powder-free, that meets all the requirements of ASTM D 5250 - 92.

This submission is for a medical device called "GG" vinyl examination gloves, powder-free, which falls under the classification of Patient examination glove (per 21 CFR 880.6250). The device is intended for medical purposes as a disposable item worn on the examiner's hand or finger to prevent contamination between the patient and examiner.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "GG" vinyl examination gloves, powder-free, are based on the ASTM standard D 5250 - 92, and FDA pinhole requirements. The document indicates that the device's performance "meets or exceeds the ASTM or equivalent standard" and "meets FDA pinhole requirements."

Note on "Reported Device Performance": The provided text explicitly states that the gloves "meet or exceed the ASTM or equivalent standard" and "meet FDA pinhole requirements." For specific numerical criteria like tensile strength and ultimate elongation, the document lists the reported values as 9.0 Mpa (min) and 300% (min) respectively, which directly match the minimum requirements. For dimension and tolerance, the table simply states "Meets/Exceeds ASTM D 5250" as specific measured values for each size are not provided, only the general standard of compliance.

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set in the same way clinical trials report them. Instead, it refers to "Inspection level S-2, AQL 4.0" for both dimension and tolerance and physical requirements. These are sampling plans specified in quality control standards (like ISO 2859-1 or MIL-STD-105E, of which AQL is a part) for attribute sampling.

• Sample Size for Test Set: Not explicitly stated as a number of devices/gloves. It refers to "Inspection level S-2, AQL 4.0," which defines a sampling plan from which sample sizes are derived based on batch size. The specific sample size for a given batch size would need to be looked up in the relevant AQL tables.
• Data Provenance: The data is generated from the manufacturer in Taiwan, R.O.C. (General Gloves Corp., No. 25, Pei Ma, 1 6 Lin, Tung Chung Village, Tung Shan Hsiang, Tainan Hsien, Taiwan 733). The data appears to be prospective as it involves performance testing of the manufactured product against established standards.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable in the context of this device. The ground truth for examination gloves is based on established engineering and material standards (like ASTM D 5250 - 92) and regulatory requirements (like FDA pinhole requirements), not on expert consensus or interpretation of medical images. The "experts" are the engineers and quality control personnel performing the tests according to the standard operating procedures derived from ASTM.

4. Adjudication Method for the Test Set

This is not applicable for this type of device testing. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image-based diagnostic studies where there's subjectivity and potential for disagreement among human readers or interpreters. For physical and dimensional testing of gloves against a standard, the results are typically quantitative measurements or pass/fail criteria based on objective methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study assesses the effectiveness of human readers (e.g., radiologists) with and without AI assistance in diagnostic tasks. Since this device is a physical examination glove, there are no "human readers" in a diagnostic context, and therefore, no AI assistance to compare.

6. Standalone (Algorithm Only) Performance

This is not applicable. This device is a physical product (gloves), not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

The ground truth for the device's performance is based on established engineering standards and regulatory requirements. Specifically:

• ASTM D 5250 - 92: This standard defines the requirements for dimensions, tensile strength, and ultimate elongation for vinyl patient examination gloves.
• FDA Pinhole Requirements: These are regulatory standards for the barrier integrity of examination gloves.

8. Sample Size for the Training Set

This is not applicable. The concept of a "training set" and "test set" in the context of machine learning or AI is not relevant to the evaluation of a physical product like examination gloves. The manufacturing process of gloves does not involve machine learning models that are "trained."

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as #8. There is no training set in the context of this device's regulatory submission.

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