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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 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)

Classified by FDA's General and Plastic Surgery Device panel as Class I. 21 CFR 880.6250. Powder-Free Nitrile Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D6319-05.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zibo Yingbo Medical Products Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free, Blue Color.

Important Note: The provided document is a 510(k) summary for a medical device (patient examination gloves). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to prove a new therapeutic effect. Therefore, the information typically requested in your prompt regarding clinical studies, human reader comparisons, and detailed ground truth establishment methods for complex algorithms is not applicable to this device. The "study" here refers to non-clinical performance testing.

Acceptance Criteria and Reported Device Performance

The device is a non-sterile, powder-free nitrile patient examination glove. Its acceptance criteria are based on compliance with established industry standards and regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For Physical and Dimensions Testing and the FDA 1000 ml. Water Fill Test, an Inspection Level S-2 and Inspection Level I, respectively, with an AQL (Acceptable Quality Limit) of 2.5 was used. The exact numerical sample size for each batch tested is not explicitly stated but is determined by the AQL and inspection level standards (e.g., ISO 2859-1 or ANSI/ASQ Z1.4 for attributes sampling plans). For biocompatibility, the sample size is also not explicitly stated, but it would typically involve animal or in vitro testing.
• Data Provenance: The tests were performed by Zibo Yingbo Medical Products Co., Ltd. on their own products. The country of origin of the data is China, where the manufacturer is located. The testing is prospective in the sense that it's performed on manufactured glove batches to ensure ongoing quality and compliance.

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

This concept is not applicable to the type of device and testing described. Ground truth for glove performance is established through objective, reproducible physical and chemical tests (e.g., tensile strength, elongation, water leak, powder residue, biocompatibility studies), not human expert consensus on interpretations.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication typically refers to resolving disagreements among human experts in interpreting data. The tests performed are objective measurements.

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 imaging AI systems where human readers interpret medical images. For patient examination gloves, the "effectiveness" is primarily determined by barrier protection, strength, and biocompatibility, which are measured objectively.

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

This concept is not applicable. This device is not an algorithm or AI system. It is a physical medical device (gloves). The performance tested is the standalone performance of the gloves themselves.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Industry Standards: Adherence to ASTM D6319-05 (Standard Specification for Nitrile Examination Gloves for Medical Application).
• Regulatory Requirements: Compliance with the FDA 1000 ml. Water Fill Test for pinholes, indicating barrier integrity.
• Biocompatibility Standards: Results from primary skin irritation and skin sensitization tests demonstrating safety for skin contact.
• Manufacturing Specifications: Ensuring powder residue meets the "powder-free" claim (less than 2 mg/glove).

These are objective, measurable criteria.

8. The Sample Size for the Training Set

This concept is not applicable. There is no "training set" in the context of a physical medical device like gloves. Training sets are used in machine learning for AI systems.

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

This concept is not applicable as there is no training set.

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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, Powder Free, Non-Sterile, Non Colored

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It primarily discusses regulatory compliance and the substantial equivalence determination for the device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study to prove the device meets those criteria based on the given text.

Ask a specific question about this device

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 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)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.

The provided text describes the 510(k) summary for the "Zibo Yingbo Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves -- Powder Free, Yellow Color."

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:

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

• Sample Size: The document mentions "samplings of AQL 2.5" and "Inspection Level S-2, AOL 2.5" for various tests. These are Acceptable Quality Limit (AQL) levels and Inspection Levels specified in quality control standards (like ASTM). While they define the statistical sampling plan (how many gloves are inspected from a lot and how many defects are allowed), they do not explicitly state the total number of gloves (sample size) actually tested for each criterion. The general practice for such tests involves taking samples from production lots.
• Data Provenance: The tests were conducted internally by Zibo Yingbo Medical Products Co., Ltd. or contracted labs on their behalf, adhering to established standards (ASTM, FDA). The provenance is specific to the manufacturer's testing of their product. No external country of origin or retrospective/prospective nature of data is mentioned beyond the manufacturing location (China) and the date the summary was prepared (Feb. 10, 2010), indicating the tests pre-date this submission.

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 to this type of device. Patient examination gloves are class I devices where performance is measured through objective physical, chemical, and biological tests based on recognized standards, not subjective expert interpretation of images or patient data. The "ground truth" is defined by passing the specified thresholds in ASTM and FDA test methods.

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

This information is not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation by multiple human readers (e.g., radiologists) is involved in determining a "ground truth" for a diagnostic algorithm. For gloves, tests are objective and follow defined protocols, so no multi-reader adjudication is necessary.

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. The device is a physical product (patient examination gloves), not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are irrelevant.

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

This is not applicable. This device is a glove, not an algorithm.

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

The "ground truth" for these gloves is established by:

• Standard Specifications: Meeting predefined physical properties (e.g., tensile strength, elongation), dimensional tolerances, and leakage resistance as outlined in ASTM D5250-06.
• Biocompatibility Standards: Demonstrating the absence of significant irritation or sensitization through specific biological tests, where "ground truth" is defined by the absence of a reaction according to test protocols.
• Chemical Analysis: Confirming the "powder-free" claim through quantitative measurement of powder content (e.g., less than 2 mg per glove).

These are all objective, measurable criteria defined by established industry and regulatory standards.

8. The sample size for the training set:

This is not applicable. This is a product that undergoes manufacturing and quality control testing, not an AI model that requires a "training set."

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

This is not applicable. There is no "training set" for this type of device.

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