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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.

Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color are Patient Examination Gloves, Disposable, single use only and non-sterile. The gloves are made of vinyl and oil-based liquid nitrile rubber materials and are powder free. The physical and performance characteristics of the devices meet all requirements of ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.

The provided document describes the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color (K142409) and seeks to prove its substantial equivalence to a predicate device (K061562). The study conducted is a non-clinical performance study comparing the subject device against the predicate device based on established standards and FDA requirements.

Here's the breakdown of the acceptance criteria and study details:

1. A table of acceptance criteria and the 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 Test Set: The sample sizes for each test are indicated by the "Inspection Level and AQL" or "N" values.
  • For physical dimensions (Overall Length, Width, Palm Thickness, Finger Thickness), Tensile Strength, and Ultimate Elongation: S-2, AQL4.0.
  • For Pinhole: G-I, AQL1.5.
  • For Residual Powder: N=5 (5 gloves tested).
  • For Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The specific number of samples (e.g., animals, human subjects, in-vitro replicates) is not explicitly stated, but the tests were performed "Under conditions of the study".
• Data Provenance: The study was conducted by Grand Work Plastic Products Co., Ltd., which is located in Zanhuang, Hebei, China. The data originates from this manufacturer. It is a prospective study as the tests were performed on the subject device to demonstrate compliance.

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 study is a physical and chemical performance test of a medical device (examination gloves), not an AI/clinical diagnostic device. Therefore, it does not involve experts establishing "ground truth" in the clinical sense (e.g., radiologists, pathologists). The "ground truth" is established by the pre-defined technical standards (e.g., ASTM D5250-06(2011), ISO 10993-10) and FDA requirements. The tests are performed by technicians in a laboratory setting according to specified protocols.

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

Not applicable. This is not a study involving human readers or clinical adjudication. The results are quantitative measurements or qualitative observations against a set standard.

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 is a performance study for a physical device (examination gloves), not a comparative effectiveness study involving human readers or AI assistance.

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

Not applicable. This is a performance study for a physical device (examination gloves), not an algorithm or AI system.

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

The "ground truth" for this study is based on established industry standards and regulatory requirements. Specifically:

• ASTM D5250-06 (Reapproved 2011) Standard Specification For Poly (Vinyl Chloride) Gloves For Medical Application.
• ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).
• FDA requirements (e.g., for pinhole AQL).

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI study; there is no training set involved.

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

Not applicable. There is no training set.

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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 Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4

The provided text describes the acceptance criteria and the study conducted for the "Shijiazhuang Hongxiang Plastic Products Co., Ltd. Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color." This is a Class I medical device (patient examination glove). The evaluation focuses on demonstrating substantial equivalence to a predicate device, as per FDA 510(k) requirements.

Here's an analysis of the provided information in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific number of gloves tested is not provided, but AQL (Acceptable Quality Limit) indicates the maximum acceptable percentage of defective items.
• Pinhole Test (Water Fill Test): AQL 2.5, inspection level G-1. The specific number of gloves tested is not provided, but AQL indicates the maximum acceptable percentage of defective items.
• Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biological tests is not specified in the document.
• Residual Powder Test: The sample size is not specified in the document.
• Data Provenance: The origin of the data is from testing performed by Shijiazhuang Hongxiang Plastic Products Co., Ltd. in China. The study appears to be prospective as it involves new testing of the device for 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 Class I examination glove, and the evaluation does not involve diagnostic interpretation that would require expert human readers to establish ground truth from medical images or clinical observations. The ground truth is objective measurements against established ASTM standards and FDA requirements.

4. Adjudication Method for the Test Set:

• Not applicable. As the tests are objective measurements against defined physical, chemical, and biological standards (e.g., AQL, mg of powder, presence/absence of irritation), there is no adjudication process involving multiple human reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is not relevant for this type of device. Such studies are typically conducted for diagnostic imaging devices or algorithms where human interpretation is a key component.

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

• Yes, in essence. The testing performed (physical, dimensional, pinhole, biocompatibility, residual powder) is equivalent to a "standalone" evaluation of the device's inherent properties without human interaction or interpretation as part of its primary function. The device itself is not an algorithm, but its performance is measured directly.

7. The Type of Ground Truth Used:

• Objective Standards and Measurement: The ground truth is established by:
  • ASTM Standards: D-5250-00E4 (physical and dimensions), D-5151-99 (pinhole/water fill), D-6124-06 (residual powder).
  • FDA Requirements: Specific pinhole requirements and biocompatibility expectations.
  • Defined Limits: E.g., no more than 2 mg powder per glove for "powder-free" claim.
  • Direct Biological Observation: For skin irritation and sensitization tests.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm or a diagnostic tool that requires a "training set." The testing is for a physical medical product.

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

• Not applicable. There is no training set for this type of device.

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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 Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4

The device described is the Grand Work Plastic Products Co., Ltd.'s Vinyl Co-Polymer Powder Free Examination Gloves, Blue Color. The submission is a 510(k) for substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance data rather than extensive clinical studies.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The specific number of items sampled is not explicitly stated but is determined by the AQL and inspection level. Data provenance is not specified but would typically be from the manufacturer's internal testing.
• Pinhole Detection (Water Fill Test): AQL 2.5, Inspection Level G-1. The specific number of items sampled is not explicitly stated. Data provenance is not specified.
• Primary Skin Irritation and Skin Sensitization: The sample size for these biological tests is not specified in the provided document. These tests are typically conducted in vitro or in vivo on animal models or human volunteers according to standard protocols. Data provenance is not specified.
• Residual Powder Test: The sample size is not specified. Data provenance is not specified.

All testing would be considered retrospective in the context of this submission, as they were performed prior to the submission for FDA clearance. The country of origin of the data is implied to be from the manufacturer's testing facilities, likely in China, given the submitter's location.

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

Not applicable for this type of device and submission. The "ground truth" for the performance tests (e.g., tensile strength, pinholes) is established by the objective physical and chemical testing methods and their predefined acceptance criteria, not by expert consensus on interpretations of complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against predetermined standards, not subjective assessments requiring adjudication among experts.

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 relevant for diagnostic devices where human readers interpret medical data (e.g., images), and the AI's impact on reader performance is evaluated. Examination gloves do not involve such human interpretation.

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. The device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements and predefined standards.

• For physical properties and dimensions, the ground truth is derived from the ASTM D-5250-00E4 standard specifications.
• For pinhole detection, the ground truth is determined by the FDA 1000 ml. Water Fill Test based on ASTM D-5151-99.
• For biocompatibility (skin irritation and sensitization), the ground truth is established by the results of standardized biological assays that demonstrate no adverse reactions.
• For residual powder, the ground truth is based on the ASTM D-6124-06 standard for starch content.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance is based on the manufacturing process and material characteristics, assessed through quality control and testing.

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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