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Powder Free Vinyl Patient Examination Gloves,White Color is a non-sterile 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,White Color are disposable devices which made of PVC material ,intended for medical purpose that worn on examiner's hand or finger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 e1.

The provided text describes a medical device called "Powder Free Vinyl Patient Examination Gloves, White Color" and its substantial equivalence to a predicate device. This is a Class I device and the submission focuses on non-clinical performance criteria based on established standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

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Powder Free Vinyl Patient Examination Gloves, White Color is a non-sterile 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, White Color that meets all of the requirements of ASTM standard D 5250-06e1.

This document describes the acceptance criteria and performance for "Powder Free Vinyl Patient Examination Gloves, White Color".

1. Table of Acceptance Criteria and Reported Device Performance:

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A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Vinyl Patient Examination Gloves, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

This 510(k) submission describes the Super Safe Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves, White. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., details on training set, experts, MRMC studies) are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific sample size for a given lot is not provided but would be determined by the AQL (Acceptable Quality Limit) and inspection level. This is a factory quality control measure, so the data provenance is from the manufacturer's internal testing in China (Shijiazhuang, Hebei, China). This is retrospective testing of manufactured products.
• Pinhole / Water Fill Test: Samplings of AQL 2.5, inspection level I. Similar to above, the specific sample size for a given lot is not provided. Data provenance is from the manufacturer's internal testing in China, retrospective.
• Primary Skin Irritation and Skin Sensitization: The document states that testing was conducted but does not specify the sample size or the data provenance beyond "with results showing." It is typically done on human subjects or animal models as per relevant ISO standards.
• Residual Powder Test: Not specified beyond "at finished inspection."

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

Not applicable. This device is a Class I medical device (patient examination gloves) and the testing described is primarily for engineering performance and biocompatibility, not for diagnostic or therapeutic efficacy requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against established standards (ASTM, FDA) for physical properties, chemical residue, and biological reactivity, not subjective interpretations requiring adjudication.

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 physical barrier (glove), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

• Physical and Dimensions Testing: The ground truth is defined by the specifications in ASTM D-5250-00E4.
• Pinhole / Water Leak Test: The ground truth is defined by the FDA 1000 ml. Water Fill Test requirements.
• Primary Skin Irritation and Skin Sensitization: The ground truth is established by standard toxicological assessment protocols, typically involving expert interpretation of skin reactions.
• Residual Powder Test: The ground truth is defined by the maximum allowable powder content (2 mg/glove) as per ASTM D6124-06.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable.

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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

The provided K051935 Premarket Notification [510(k)] Summary pertains to "Powder Free Vinyl Patient Examination Gloves, White (non-colored)". This device is a medical glove, and the acceptance criteria and study detailed are for demonstrating its compliance with relevant standards and safety.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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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 (white, yellow) that meets all of the requirements of ASTM standard D 5250-0084.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and noting areas where the information is not present:

Acceptance Criteria and Device Performance

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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

This is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. The information provided is standard for this type of device and does not involve complex AI algorithms or detailed clinical studies in the way you might expect for an AI-powered diagnostic tool. Therefore, many of your requested items, such as expert adjudication, MRMC studies, and detailed training set information, are not applicable in this context.

Here's an analysis based on the provided document:

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

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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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0064

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the requested format.

It's important to note that this document is a 510(k) summary for a general medical device (patient examination gloves). As such, the "study" referred to is primarily non-clinical testing against established standards, not a clinical trial in the way one might think of it for drug development or complex diagnostic AI. The questions provided in the prompt are more geared towards AI/software as a medical device (SaMD) evaluations, so some sections will reflect that the information is not directly applicable or available in this type of submission.

Acceptance Criteria and Device Performance

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

Ask a specific question about this device

This 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, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4.

Requested information about the acceptance criteria and study that proves the device meets the acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

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