Search Results

A powder free patient examination glove (Tested for Use with Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner. These gloves are not intended to be used as a chemical barrier.

Sunmax Enterprise Shanghai Co Powder free blue Nitrile Examination Glove is a class II device having product code 80LZA. It is a disposable device that meets all requirements of ASTM D 631900a-05 and is tested with chemotherapy drugs.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a patient examination glove, and its performance is assessed against established ASTM standards and specific physical characteristics. The document doesn't explicitly state "acceptance criteria" as a distinct section but lists characteristics and test results that imply acceptance based on meeting these values or passing these tests.

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

• Sample Size: The document does not specify a separate "test set" sample size for the various tests. It generally refers to testing being conducted to meet ASTM standards. For pinholes and general inspection, it mentions "Inspection level S-2, AQL 4.0, pinholes at AQL 2.5," which are statistical sampling plans defined within the ASTM standard, but not explicit sample numbers.
• Data Provenance: Not explicitly stated. The manufacturer is in Shanghai, China, so it's most likely that the testing was performed there. It's retrospective in the sense that the data is presented as a summary of completed tests for the 510(k) 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 "ground truth" as typically defined for diagnostic or AI-driven devices (e.g., expert consensus on images, pathology reports) is not relevant. The performance is assessed through standardized physical, chemical, and biological tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" are used for expert review where there might be disagreement, usually for image interpretation or similar qualitative assessments. For material property testing, the results are quantitative and objective measurements or pass/fail criteria against a 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 not an AI-driven device or a diagnostic device where human readers would be involved in interpretation.

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

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

7. The Type of Ground Truth Used

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

• ASTM Standard Specifications: Specifically, ASTM D 6319-00a-05 for physical properties and dimensions.
• Permeation Testing per ASTM D 6978-05: For chemotherapy drug resistance, the "ground truth" is whether the glove prevents breakthrough for a specified duration according to this standard.
• Biocompatibility Testing: "Passes" results for dermal sensitization and primary skin irritation tests establish the ground truth for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. No training set is involved.

Ask a specific question about this device

A powderfree patient examination glove is a disposable device that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Sunmax Blue Nitrile Powderfree Examination Glove

This document is a 510(k) premarket notification from Sunmax Enterprises Shanghai Company Limited for their Sunmax Blue Nitrile Powder Free Examination Glove. The FDA has found the device substantially equivalent to legally marketed predicate devices.

The document does not detail specific acceptance criteria or a study that proves the device meets those criteria in the way envisioned by the request. Instead, it indicates that the device has been deemed "substantially equivalent" to predicate devices already on the market. In the context of a 510(k) submission for this type of medical device (examination gloves), substantial equivalence is typically established by demonstrating that the new device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that it does not raise new questions of safety and effectiveness and is as safe and effective as the predicate.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment, which are common for higher-risk devices or more complex software/AI-based medical devices, are not explicitly present or applicable in this 510(k) for an examination glove.

However, based on general FDA requirements for examination gloves and the information provided, we can infer some aspects:

1. A table of acceptance criteria and the reported device performance:
   The document doesn't provide a table of acceptance criteria for performance like accuracy, sensitivity, or specificity. For examination gloves, acceptance criteria usually relate to physical properties and barrier integrity. These would typically include:

   Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
   Barrier Integrity (e.g., AQL for pinholes)	Passed (implied by substantial equivalence)
   Tensile Strength	Met (implied by substantial equivalence)
   Elongation	Met (implied by substantial equivalence)
   Dimensions	Met (implied by substantial equivalence)
   Biocompatibility (skin irritation, sensitization)	Met (implied by substantial equivalence)
   Powder-free status	Met (as per device name "Powder Free")

   The "reported device performance" is not explicitly stated but is implied to meet the necessary standards for substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance: There is no specific test set sample size or data provenance mentioned in this document. For gloves, testing is typically done on batches, and the FDA would evaluate manufacturing controls, not a clinical trial with a "test set" in the AI or diagnostic sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For examination gloves, performance is assessed through standardized physical and chemical tests, not through expert-established ground truth on a test set.

4. Adjudication method for the test set: Not applicable.

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 an examination glove, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would be laboratory measurements and adherence to recognized standards (e.g., ASTM standards for medical gloves) and FDA guidance for physical properties, rather than diagnostic outcomes.

8. The sample size for the training set: Not applicable. This is not a machine learning device.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) letter confirms the regulatory clearance based on substantial equivalence, rather than detailing a specific performance study with acceptance criteria in the manner requested for complex diagnostic or AI devices. The information provided is typical for a Class I medical device like an examination glove.

Ask a specific question about this device

A powdered patient examination glove is a disposable device made of nitrile for medical purposes that is worn upon the hand to prevent contamination between patient and examiner.

Sunmax Blue Nitrile Powdered Examination Gloves

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria. The text is a 510(k) premarket notification letter from the FDA regarding "Sunmax Blue Nitrile Powdered Examination Gloves." It discusses the substantial equivalence of the gloves to a legally marketed predicate device and confirms that the company can begin marketing them.

The document includes:

• A letter from the FDA approving the 510(k) application (K011717) for the Sunmax Blue Nitrile Powdered Examination Gloves.
• An "Indications For Use Statement" for the gloves, describing them as "a disposable device made for medical purposes to prevent contamination between patient and examiner."

It does not contain:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance, or expert qualifications for ground truth.
• Details on adjudication methods, MRMC studies, or standalone algorithm performance.
• Information about training sets or how their ground truth was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device

Ask a specific question about this device

A glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel the patient's body, and fluids, waste or environment.

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Vinyl Patient Examination Glove, 80LYZ, Powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

Acceptance Criteria and Device Performance Study

This document describes the acceptance criteria and the study that demonstrates the device meets these criteria. The device in question is the Sunmax Enterprise Shanghai Co., Ltd. Vinyl Patient Examination Gloves - Powdered.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of an algorithm or AI model, as this is a medical device (gloves). Instead, the listed tests refer to quality control and performance testing for the manufacturing and physical properties of the gloves.

• Physical Dimensions and Testing: Inspection Level S-2, AQL 4.0. The exact sample size for this inspection level is not provided but is a standard statistical sampling plan for quality control.
• FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4. The exact sample size for this inspection level is not provided but is a standard statistical sampling plan for quality control.
• Primary Skin Irritation and Skin Sensitization: The sample size for these biocompatibility tests is not specified in the provided text.
• Data Provenance: The tests were conducted by Sunmax Enterprise Shanghai Co., Ltd. in China. The document does not specify if the data is retrospective or prospective, but given the context of product testing for 510(k) submission, it would generally be prospective testing conducted on new production batches.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a physical medical device (gloves), not an AI/algorithm-driven device requiring expert-established ground truth for a test set. The performance is assessed against established physical and biocompatibility standards.

4. Adjudication Method

Not applicable. As this involves physical device testing against established standards, an adjudication method for reconciling different expert opinions on ground truth is not relevant.

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

Not applicable. This device is a physical medical device (gloves), not an AI system that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

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

Not applicable. This device is a physical medical device (gloves), not an algorithm or software. Its performance is inherent to its physical properties and material.

7. Type of Ground Truth Used

The "ground truth" for the performance of these gloves is established by:

• Standard Specifications: Compliance with ASTM Standard D5250-92 for physical dimensions and testing.
• Regulatory Test Methods: Compliance with the FDA 1000 ml. Water Fill Test for pinhole integrity.
• Biocompatibility Testing: Results from primary skin irritation and skin sensitization tests, which are objective measures of biological response.

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device (gloves), there is no "training set" in the context of machine learning or algorithm development. The "training" for glove manufacturing would involve process control and quality assurance to ensure consistent product output.

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

Not applicable, as there is no "training set" for an algorithm. The manufacturing process of the gloves is designed and controlled to meet the established standards and specifications, which serve as the "ground truth" for product quality. This is established through engineering design, material specifications, quality management systems (e.g., FDA's GMPs), and adherence to industry standards like ASTM.

Ask a specific question about this device