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Powder-Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

This document is a 510(k) summary for the Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device, rather than a traditional study proving a device meets specific acceptance criteria for a new clinical claim. Therefore, the information provided will be structured to align with the content of this regulatory submission.

1. Acceptance Criteria and Reported Device Performance (Summary of Equivalence to Predicate)

The device demonstrates substantial equivalence by meeting the same ASTM standards and regulatory requirements as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of a typical clinical study. The performance characteristics for the Yongchang Powder-Free Yellow Vinyl Patient Examination Gloves were evaluated against established ASTM standards (D5250, D5151, D6124) and FDA regulations (21 CFR 800.20).

• Sample sizes for testing: The specific sample sizes used for each test (e.g., tensile strength, pinholes, residual powder) are not explicitly stated in this summary. These would typically be defined within the referenced ASTM standards.
• Data Provenance: The device is manufactured by Ideal Plastic Co., Ltd. in China. The testing would have been conducted by or for the manufacturer, likely in China or by certified laboratories. The data itself is "nonclinical" and laboratory-based, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable in the context of this 510(k) submission. This type of submission relies on conformity to established engineering and material standards, and bench testing, rather than expert-derived ground truth from complex medical images or clinical scenarios. The "ground truth" here is the adherence to the specifications outlined in the ASTM standards and FDA regulations, verified through standardized testing methods.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a conformity assessment based on standardized tests, not an expert-driven adjudication process.

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

Not applicable. This device is a Class I patient examination glove, and its substantial equivalence is demonstrated through physical and chemical property testing, not through MRMC studies comparing human reader performance. Its function is as a barrier, not an interpretative tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device (glove), not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" is defined by the established performance specifications within the referenced ASTM standards (D5250-06, D5151-06, D6124-06) and FDA regulations (21 CFR 800.20), along with the biocompatibility requirements of ISO 10993-10. The device's performance is compared directly to these objective, quantitative standards.

8. Sample Size for the Training Set

Not applicable. This is a physical device, and the concept of a "training set" for an algorithm does not apply. The manufacturing process is controlled to ensure consistent product attributes, not to "train" a model.

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

Not applicable, for the same reasons as point 8.

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Powder-Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided text describes the 510(k) summary for Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves (K152719). This document is a premarket notification for a medical device and therefore focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new performance criteria.

As such, the information you've requested regarding acceptance criteria, study details, ground truth, and sample sizes is framed within the context of meeting established ASTM (American Society for Testing and Materials) standards for patient examination gloves, rather than a standalone clinical study on the device's diagnostic performance. The device is a physical product (gloves) and not an AI/software device, so many of the questions regarding AI-specific studies (MRMC, standalone algorithm performance) are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves are primarily defined by adherence to specific ASTM standards and FDA regulations. The reported device performance is presented as meeting these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the specific sample sizes for each test in the batch of gloves. It refers to meeting ASTM standards, which would imply that the testing followed the sampling methodologies outlined in those standards (e.g., AQL levels for pinhole testing).
• Data Provenance: The tests are conducted on the manufactured "Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves" by Xinfu Medical Products Co., Ltd. The testing would be conducted in China (East of Lipingtuo, Luannan County, Tangshan City, 063502 Hebei Province, China) and are likely retrospective data from product testing batches.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable in the context of this device. The "ground truth" for these physical performance tests (e.g., glove dimensions, tensile strength, pinholes, residual powder) is established by adherence to quantitative and qualitative criteria defined within the referenced ASTM standards, not by expert consensus in a diagnostic sense. These tests are performed by laboratory technicians or quality control personnel using calibrated equipment and standardized procedures.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements or binary pass/fail based on established standards, not subjective assessments 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 medical glove, not an AI/software device. Therefore, no MRMC study or AI performance evaluation was conducted.

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

Not applicable. This device is a physical medical glove, not an AI/software device. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is the adherence to the quantitative and qualitative specifications outlined in the referenced ASTM standards and FDA regulations. For example:

• Dimensions: Measured values must fall within the ranges specified by ASTM D5250-06.
• Tensile Strength/Elongation: Measured values must meet or exceed the minimum requirements of ASTM D5250-06.
• Freedom from Pinholes: The number of pinholes in a sample must meet the Acceptable Quality Level (AQL) of 2.5 per ASTM D5151-06 and 21 CFR 800.20.
• Residual Powder: The measured powder residue must be below the limit specified by ASTM D6124-06 (below 2mg).
• Biocompatibility: Results from established biological tests (e.g., ISO 10993-10) must indicate non-irritancy and non-sensitization.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/machine learning model that requires a training set. The compliance is based on testing production samples against established standards.

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

Not applicable, as there is no training set for a physical product like a patient examination glove.

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Powder Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions: PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device 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.
-- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.

The document describes a 510(k) premarket notification for "Powder-Free Yellow Vinyl Patient Examination Gloves" (K143347). The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, which is also a Powder-Free Vinyl Patient Examination Glove, Yellow Color (K122920).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is evaluated against ASTM standards and FDA requirements. The table below summarizes the key acceptance criteria and the device's reported performance, as it is claimed to meet these standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for pinholes, tensile strength, etc.). However, it indicates compliance with recognized standards that would implicitly define appropriate sampling plans.

• Data Provenance: The testing appears to have been conducted by the manufacturer, Zibo Zhouheng Plastic Products Co. Ltd, in China, to demonstrate compliance with international and US standards. The data is retrospective, as it refers to tests conducted on the manufactured device for submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device submission. The "ground truth" for medical gloves is established by their adherence to defined performance specifications and safety standards (e.g., ASTM, ISO, FDA regulations) as measured through physical and chemical testing, not by expert consensus on clinical images or diagnoses.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology reads) where discrepancies between experts need to be resolved. For glove testing, results are objective measurements against defined criteria.

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. MRMC studies and the concept of AI assistance for human readers are relevant to AI/ML-driven diagnostic devices, not patient examination gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical medical glove, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device is based on established performance standards and regulatory requirements. Specifically:

• ASTM Standards: ASTM D5250-06 (Reaffirmation 2011) for vinyl patient examination gloves, ASTM D5151-06 (Reapproved 2011) for freedom from holes, and ASTM D6124-06 (Reaffirmation 2011) for residual powder.
• FDA Regulations: 21 CFR 800.20 for barrier integrity.
• ISO Standard: ISO 10993-10 Third Edition 2010-08-01 for biocompatibility (skin irritation and sensitization).

These standards define the acceptable physical properties, barrier integrity, and biological safety of the gloves.

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 device is a physical product and does not involve AI/ML. All testing mentioned constitutes part of the validation process against established standards.

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

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

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Powder-Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

The provided text is a 510(k) summary for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a device's performance against specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves an AI device meets acceptance criteria simply do not apply to this document, as it concerns a medical glove and not an AI/ML device.

However, I can extract the relevant information from the document that is analogous to "acceptance criteria" and "reported device performance" for this specific product, a patient examination glove.

Here's the closest interpretation of your request based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for the Hongyun Powder-Free Yellow Vinyl Patient Examination Gloves are defined by their conformance to specific ASTM standards and FDA regulations. The "reported device performance" is the statement that the device meets these standards.

The study proving the device meets these criteria is an internal non-clinical testing program conducted by the manufacturer, Tangshan Hongyun Plastic Products Co.,ltd, to ensure compliance with the referenced ASTM standards and ISO standard for biocompatibility.

Regarding the requested information for AI/ML devices (which are not applicable to this document):

2. Sample size for the test set and data provenance: Not applicable. The "test set" here refers to samples of gloves tested according to ASTM standards. The document does not specify exact sample sizes for each test, but rather refers to conformance with standards which typically define sampling plans. The data provenance is internal testing by the manufacturer in China.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical product like a glove is established by standardized measurement methods defined in ASTM standards, not by expert consensus in the way an AI algorithm's output might be.
4. Adjudication method for the test set: Not applicable. Testing for physical properties follows specific protocols defined by the ASTM and ISO standards.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant for a medical glove.
6. Standalone (algorithm only) performance study: Not applicable. This device is not an algorithm.
7. Type of ground truth used: For physical properties, the "ground truth" is the quantitative measurement obtained through standardized tests (e.g., length in mm, thickness in mm, tensile strength in MPa, AQL for pinholes, residual powder in mg/glove, biological response for biocompatibility).
8. Sample size for the training set: Not applicable. This concept is for AI/ML models. For manufacturing, there are quality control processes, but not a "training set" in this context.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device (gloves), not an AI/ML device. Therefore, most of the questions relating to AI/ML study design are not addressed. The "acceptance criteria" are the established ASTM and ISO standards, and the "study" is the non-clinical testing performed by the manufacturer to demonstrate compliance with these standards.

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

The proposed device, Powder Free Yellow Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. The proposed is Powder Free Yellow Vinyl Patient Examination Gloves, and includes variations of different size.

The provided text describes the 510(k) summary for "Powder Free Yellow Vinyl Patient Examination Gloves." This is a premarket notification for a Class I medical device (patient examination glove), which is regulated under 21 CFR 880.6250. The submission aims to demonstrate substantial equivalence to a predicate device (K091431).

Given that this is a 510(k) submission for a low-risk device like examination gloves, the "acceptance criteria" primarily relate to compliance with recognized standards and demonstrating equivalence to a predicate device rather than complex clinical endpoints or AI model performance. The "study" here refers to bench tests and biocompatibility assessments.

Here's a breakdown based on your request:

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

The acceptance criteria are derived from recognized standards (ASTM, ISO) and comparison to the predicate device. The reported performance aligns with these standards.

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

The document explicitly mentions the use of ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection." This standard details how sample sizes are determined for inspection based on the lot size and acceptable quality levels for attributes like holes, dimensions, and physical properties.

• Sample Size: While the exact number of gloves or batches tested is not explicitly stated in this summary, it refers to ISO 2859-1 for sampling procedures, implying that samples were drawn from production lots according to this standard. For biocompatibility, standard practice involves a sufficient number of samples to represent the device and achieve statistically significant results (e.g., typically 3 device samples for in vitro tests, and appropriate animal numbers for in vivo tests as per ISO 10993-10).
• Data Provenance: The tests were conducted by Zibo Huaqi Trading Company, Limited, which is based in China. The nature of these tests (bench tests, biocompatibility) implies they were prospective in the sense that they were specifically designed and executed for this 510(k) submission on samples of the manufactured device.

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 to this type of device. "Ground truth" and "experts" in the context of clinical interpretation (like radiologists) are relevant for diagnostic imaging or AI devices. For patient examination gloves, the "ground truth" is established by direct physical measurements, chemical analysis, and standardized biological assessments conducted by trained lab personnel following the protocols outlined in the referenced ASTM and ISO standards. There are no clinical interpretation experts involved in establishing the "ground truth" for the physical and biological characteristics of a glove.

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

This section is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers assess cases and a consensus or tie-breaker mechanism is used to establish ground truth, particularly in the context of diagnostic performance or AI evaluation. For bench testing of gloves, results are typically objective measurements or observations (e.g., pass/fail for holes, numerical values for tensile strength) that do not require clinical 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

This section is not applicable. This device is a disposable patient examination glove; it does not involve any AI, human readers, or diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is entirely irrelevant to this submission.

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

This section is not applicable. The device is a physical glove, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for the performance of these gloves is established through adherence to recognized international and national standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 2859-1, ISO 10993-10). The "truth" is whether the glove samples meet the specified physical, dimensional, and biological requirements outlined in these standards. This involves:

• Direct Physical Measurement: For dimensions (length, width, thickness).
• Controlled Testing Procedures: For tensile strength, elongation, hole detection, powder content.
• Standardized Biocompatibility Tests: According to ISO 10993-10 for irritation and sensitization, which involves animal or in vitro tests as specified by the standard.

There is no "expert consensus" in the clinical sense, pathology, or outcomes data used to establish glove ground truth.

8. The sample size for the training set

This section is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI. The manufacturer's production processes and quality control systems would be refined over time (akin to "training" in a broad sense), but there is no specific quantifiable training set size as for an algorithm.

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

This section is not applicable for the same reason as point 8. There is no training set for a physical device. The manufacturing process is validated against specifications to ensure consistent quality.

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Powder-Free Yellow Vinyl Patient Examination Gloves 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 Yellow Vinyl Patient Examination Gloves that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).

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

Device: Powder-Free Yellow Vinyl Patient Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The study proving the device meets the acceptance criteria is a nonclinical study focused on demonstrating substantial equivalence to a predicate device.

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

• The document does not explicitly state the sample size used for testing each specific characteristic (e.g., number of gloves tested for length, width, tensile strength, pinholes, residual powder, or biocompatibility).
• The data provenance is China (Zibo Litong Plastic Products Co., Ltd. is located in Zibo, Shandong, China).
• The study is retrospective in the sense that it relies on product testing to demonstrate conformance to existing standards and comparison to a legally marketed predicate device, rather than a new prospective clinical trial.

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

• The document does not specify the number of experts or their qualifications for establishing ground truth for the test set. The "ground truth" here is defined by established performance standards (ASTM standards, 21 CFR regulations, ISO standards) and comparison to a predicate device. The testing would have been conducted by trained personnel in a laboratory setting.

4. Adjudication method for the test set:

• The document does not describe an adjudication method in the context of expert review for the test set. The assessment appears to be based on direct measurement and laboratory testing against pre-defined quantitative and qualitative 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 diagnostic imaging AI devices involving human interpretation. This device is a patient examination glove, and the regulatory pathway does not require or involve such studies.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical medical device (glove), not a software or AI algorithm.

7. The type of ground truth used:

• The ground truth used is primarily based on established industry standards and regulatory requirements, including:
  • ASTM D5250-06 (Reaffirmation 2011) - for physical properties, dimensions, etc.
  • ASTM D5151-06 (Reapproved 2011) - for freedom from pinholes (water leak test).
  • ASTM D6124-06 (Reaffirmation 2011) - for residual powder.
  • 21 CFR 800.20 - for freedom from pinholes.
  • ISO 10993-10 (2002/Amd.1:2006 and Third Edition 2010-08-01) - for biocompatibility (skin irritation and sensitization).
  • The characteristics of a legally marketed predicate device (Hebei Leader Plastic Co., Ltd. K122920) serve as a comparative ground truth for demonstrating substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for a machine learning model, no ground truth was established for it.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250) .

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

This document is a 510(k) clearance letter from the FDA for "Patient Vinyl Examination Gloves, PowderFree, Non-Sterile." It grants market clearance based on substantial equivalence to existing devices. As such, it does not contain the detailed study information regarding acceptance criteria and performance of a new medical device that you're looking for.

Instead, this letter confirms that the device is a Class I medical device and is subject to general controls. For these types of devices, performance testing often focuses on established standards (e.g., ASTM standards for gloves) and equivalence rather than complex clinical studies with ground truth establishment and MRMC analysis.

Therefore, I cannot extract the information you requested from this document. The document primarily focuses on regulatory clearance, not detailed device performance study results.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, PowderFree, Non-Sterile

This document is an FDA 510(k) clearance letter for "Patient Vinyl Examination Gloves, PowderFree, Non-Sterile." It explicitly states that the device is substantially equivalent to legally marketed predicate devices and does not require approval of a Premarket Approval Application (PMA).

However, the provided text does not contain any information about acceptance criteria, a study, or performance data for the device. The letter is an administrative notification of clearance based on equivalence, not a detailed report of a device's performance against specific criteria.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set.
• Data provenance for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method.
• Whether an MRMC comparative effectiveness study was done or its effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Yellow, Powder free, Non-Sterile

This document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It primarily addresses regulatory approval and does NOT contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information from the provided text.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
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 document describes the testing and acceptance criteria for Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s Powder Free (Yellow) Vinyl Patient Examination Gloves.

Here is the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Pinhole (Water Fill Test): "samplings of AQL 2.5, inspection level I" - The exact sample size is not explicitly stated, but it would be determined by the AQL and inspection level, referencing ISO 2859-1 or a similar standard.
• Physical Dimensions & Quality System: "Inspection level S-2, AQL 4.0" - Similar to the pinhole test, the exact sample size is not explicitly stated.
• Biocompatibility & Residual Powder: Sample sizes were not specified in the provided document.
• Data Provenance: The tests were conducted by the manufacturer, Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd., in China. The data would be considered retrospective as it was conducted on finished products for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a medical glove, and its performance is evaluated against engineering standards and material properties, not through expert human interpretation or diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against established standards (e.g., water fill for pinholes, chemical analysis for powder, physical measurements for dimensions). No human adjudication of differing interpretations is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of results (e.g., radiology images), not for a medical device like an examination glove.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described is effectively standalone performance. The device's characteristics (physical properties, absence of pinholes, biocompatibility, powder residue) were measured directly without human intervention or interpretation that would alter the test outcome.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Industry Standards: Adherence to ASTM standard D-5250-00E4 for physical and dimensional characteristics, and ASTM D-6124-06 for residual powder.
• Regulatory Requirements: Adherence to FDA's 1000 ml. Water Fill Test for pinholes, and biocompatibility testing requirements.
• Objective Measurements: These standards and requirements define objective, measurable performance criteria.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set." The product is manufactured and then tested for compliance.

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

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

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