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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

The subject device is disposable medical PVC gloves that made from PVC compound, Clear (non-colored), powder free and nonsterile. The device meets the specifications in ASTM D5250-06(Reapproved 2015) Standard specification for poly (vinyl chloride) gloves for medical application.

This document is a 510(k) Premarket Notification summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". It describes the device, its intended use, and the studies conducted to demonstrate substantial equivalence to a predicate device.

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:

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Powder Free Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Vinyl Patient Examination Gloves Are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-19 Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application.

The provided document describes the acceptance criteria and performance data for Powder Free Vinyl Patient Examination Gloves (K211177). This is a medical device, and the data provided relates to its physical performance and biocompatibility, not an AI/ML-based diagnostic or imaging device. Therefore, many of the requested fields (such as sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, and ground truth types related to AI/ML) are not applicable (N/A) for this type of medical device submission.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Pinhole Test: 125 gloves were sampled.
• Other Physical and Biocompatibility Tests: Sample sizes are not explicitly stated for all tests but are implied by the standards referenced (e.g., "N=5" for residual powder).
• Data Provenance: The manufacturer is Shijiazhuang Hongjun Plastic Manufacture Co., Ltd. located in Shijiazhuang City, Hebei Province, China. The testing was conducted to meet international and US standards (ASTM, ISO, CFR). Specific country of origin for data collection for these non-clinical tests is not detailed beyond the manufacturer's location, but the tests generally follow standardized laboratory protocols rather than clinical data collection. This would be considered prospective testing against established specifications, not retrospective clinical data.

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

• N/A. This is not relevant for the type of device and testing performed. The "ground truth" for these tests is defined by the objective physical and chemical properties measured against recognized industry standards (ASTM, ISO). No expert clinical assessment of "ground truth" is involved.

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

• N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical studies or expert evaluations, which is not applicable here. The tests are objective measurements based on specified standard methods.

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

• N/A. This is a physical non-diagnostic product (gloves). MRMC studies are for evaluating diagnostic tools involving human interpretation, often in conjunction with AI.

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

• N/A. This device does not have an algorithm or AI component.

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

• The "ground truth" is defined by established engineering and material science standards and specifications (e.g., ASTM D5250-19, ISO 10993-10, ISO 10993-5, ASTM D6124-06, ASTM D5151-19). These standards provide objective, measurable criteria for acceptable performance and biocompatibility.

8. The sample size for the training set

• N/A. This is a physical non-diagnostic product. There is no "training set" in the context of AI/ML.

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

• N/A. This is a physical non-diagnostic product. No AI/ML training set or associated ground truth establishment method is applicable.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document pertains to the 510(k) premarket notification for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored). The information provided heavily focuses on proving substantial equivalence to a predicate device through non-clinical performance data, primarily compliance with established ASTM and ISO standards for medical gloves.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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The Powder Free Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is colorless. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This document describes the premarket notification for the "Powder Free Vinyl Patient Examination Glove" (K210799). It is a Class I device and the submission focuses on demonstrating substantial equivalence to a predicate device (K163168).

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

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

The acceptance criteria are implicitly defined by compliance with specific ASTM and ISO standards, and by showing equivalence to the predicate device, particularly regarding physical properties and biocompatibility.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

Poly Vinyl Chloride (PVC) films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a novel device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested sections are not applicable in this context. However, I can extract information related to the device's technical specifications and the non-clinical tests performed to ensure it meets established safety and performance standards for gloves.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally defined by compliance with established ASTM and ISO standards for medical examination gloves. The reported device performance is presented as meeting these standards.

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

The proposed device is Powder Free Examination Gloves. The proposed device is Clear (non-colored). The proposed device is non-sterile.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what's available and noting what's not:

1. Table of Acceptance Criteria and Reported Device Performance

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.

The provided text describes the 510(k) submission for Anhui Intco Medical Products Co. Ltd.'s Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered medical device through a clinical study.

Therefore, most of the requested information regarding AI device acceptance criteria and study details (such as MRMC studies, standalone algorithm performance, AI training/test set ground truth, and expert qualifications for ground truth establishment) is not applicable to this document.

However, I can extract information related to the performance characteristics that were tested for these medical gloves to demonstrate substantial equivalence.

Here's the information that is applicable based on the provided document:

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

The document compares the subject device (K191092) to a predicate device (K022091) across various physical and biocompatibility characteristics. The "acceptance criteria" here are essentially the performance levels of the predicate device or established standards (like ASTM).

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Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) 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.

PVC films form a barrier to prevent contamination between patient and examiner. The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. The Poly (vinyl chloride) glove acts as a barrier to prevent contamination between patient and examiner. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151.

This document, K182575, is a 510(k) Premarket Notification for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". As such, it does not contain the type of acceptance criteria and study data typically associated with a "device" in the context of an AI/ML medical device, which would involve performance metrics like accuracy, sensitivity, specificity, and a detailed human-in-the-loop (HITL) study.

This submission is for a Class I medical device (patient examination glove), which, by regulation, has a much lower bar for demonstrating substantial equivalence to a predicate device. The "performance data" here refers to physical and biological characteristics of the glove, not diagnostic or predictive performance.

Therefore, I cannot provide the requested information in the format of AI/ML device studies because the provided document does not pertain to such a device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to manufacturing and material standards, not clinical diagnostic accuracy.

However, I can extract the information relevant to this specific device type and its "studies":

Acceptance Criteria and Device Performance (for a physical medical device: Examination Glove)

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

Powder Free Vinyl Patient Examination Gloves are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly(Vinyl Chloride) Gloves For Medical Application.

This document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves," a Class I medical device. The information provided pertains to the substantial equivalence of the subject device to a predicate device, focusing on non-clinical performance characteristics to demonstrate safety and effectiveness.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The acceptance criteria are generally established by the ASTM D 5250-06 (Reapproved 2015) Standard Specification for Poly(Vinyl Chloride) Gloves For Medical Application. The predicate device and the subject device both aim to meet these requirements.

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

The document does not explicitly state the specific numerical sample sizes for each test. Instead, it refers to "Inspection Level and AQL" (Acceptable Quality Level) from the ASTM standards for some tests (e.g., S-2, AQL 4.0 for dimensions and tensile strength; G-I, AQL 2.5 for pinhole). These AQLs imply a sampling plan rather than a fixed sample size.

• Pinhole: Inspection Level G-I, AQL 2.5.
• Dimensions, Tensile Strength, Ultimate Elongation: Inspection Level S-2, AQL 4.0.
• Residual Powder: N=5 (5 gloves were tested).
• Biocompatibility Tests (Primary Skin Irritation, Dermal Sensitization, Cytotoxicity Test): No sample sizes are specified for these in the table; the results are qualitative ("not an irritant," "not a cytotoxic potential").

The data provenance is from Shanxi Hongjin Plastic Technology Co., Ltd in China, as indicated by their address on the document. The studies are non-clinical lab tests conducted to support the 510(k) submission, implying a prospective data generation process for the purpose of regulatory approval.

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)

This section is not applicable as the device is a medical glove, and the "ground truth" is based on objective physical, chemical, and biological performance characteristics measured by laboratory tests and adherence to industry standards (ASTM D5250-06), not expert medical interpretation of images or clinical outcomes.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiologists reading medical images) to establish consensus ground truth. The tests for these gloves are objective measurements.

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 is not applicable. This type of study relates to AI-assisted diagnostic devices and human reader performance, not physical medical devices like examination gloves.

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

This is not applicable. This concept applies to AI/software as a medical device, where the algorithm performs a task independently. The tests performed here are direct measurements of a physical product's attributes.

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

The "ground truth" for this device's performance is established by objective measurements against pre-defined specifications and compliance with recognized industry standards, specifically ASTM D 5250-06 (Reapproved 2015). For biocompatibility, it's based on standard biological evaluation tests determining if the material is an irritant or cytotoxic.

8. The sample size for the training set

This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the testing and performance of a physical product according to established standards, not an AI/ML device.

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

This is not applicable for the same reasons as point 8.

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

Powder Free Vinyl Patient Examination Gloves (Yellow, White) are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2015) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

This document is a 510(k) Pre-Market Notification for Powder Free Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through clinical studies in the typical sense of AI/software devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" here refer to compliance with recognized standards and performance thresholds for examination gloves.

Here's a breakdown of the requested information based on the provided text, interpreted in the context of a medical glove submission:

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

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

• Sample Size for Test Set: The sample sizes are indicated by the "Inspection Level and AQL" (Acceptable Quality Limit) for most physical and performance tests, such as S-2, AQL4.0, and G-I, AQL2.5. For Residual Powder, the sample size was N=5. These AQL levels refer to sampling plans (e.g., ISO 2859-1 or ANSI/ASQ Z1.4), where a specific number of units are inspected from a lot, and the lot is accepted or rejected based on the number of defects found. The exact number of units tested isn't explicitly stated but would be determined by the AQL tables for the lot size.
• Data Provenance: The manufacturing entity is Shanxi Hongjin Plastic Technology Co., LTD, located in China. The testing would have been conducted by or on behalf of this company. The data is prospective in the sense that it's generated for the purpose of demonstrating compliance for this submission.

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)

This product is a medical device (patient examination gloves) tested against recognized physical, chemical, and biological standards. "Ground truth" in this context is established by the accepted scientific methodologies and criteria outlined in the ASTM and ISO standards, rather than expert human interpretation in the way it applies to diagnostic AI. Therefore, there are no "experts" in the sense of clinicians establishing ground truth for individual cases. The ground truth is the objective measurement against the specified standard requirements.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image reading). For device performance testing against quantitative standards, the measurements are objective.

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 product (medical glove), not an AI or software algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance tests in this submission is the objective measurement against scientifically established and recognized standards (e.g., ASTM D5250-06 for physical properties, specific thresholds for residual powder, and standard biocompatibility tests for irritation and sensitization). It is not pathology, outcomes data, or expert consensus on a diagnostic interpretation.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no training set in that context. Statistical sampling is used for quality control during manufacturing and for conformity testing.

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

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