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A patient examination glove is disposable device intended for medical a 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, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1.

The provided document describes the acceptance criteria and the study performed for a medical device: Better Care Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• ASTM D-5250-06e1 Testing: The document states "Inspection level S-2, AQL 4.0" for physical and dimensions testing. AQL (Acceptable Quality Limit) and inspection level are metrics for sampling, but the precise sample size in numbers is not explicitly stated.

• FDA 1000 ml. Water Fill Test: "Samplings of AQL 2.5, inspection level I" were conducted. Again, a precise numerical sample size is not provided, but these metrics define the sampling plan.

• Primary Skin Irritation and Skin Sensitization: The sample size for these tests is not specified in the document.

• Residual Powder Test: The sample size for this test is not specified.

• Data Provenance: The studies were performed by Better Care Plastic Products Co., Ltd. for their product. The location of the company is Fuqian Xi Road, West district of Shenze Industrial Base, Shenze County, Hebei Province 050000 (China). The data is retrospective as it was collected before the 510(k) submission.

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

• This information is not applicable as the tests performed are primarily laboratory-based performance and safety tests for examination gloves, not diagnostic studies requiring expert review of medical images or data. Ground truth here refers to the objective results of the specified physical, chemical, and biological tests.

4. Adjudication Method for the Test Set

• This is not applicable. The tests are objective and performed according to established ASTM standards and FDA protocols (e.g., water fill test). There is no "adjudication" in the sense of reconciling differing expert opinions, as the results are determined by the test procedures themselves.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• This is not applicable. The device is an examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.

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

• This is not applicable. The device is an examination glove and does not involve any algorithms or AI for standalone performance evaluation.

7. The Type of Ground Truth Used

• The ground truth for this device is based on objective measurements and laboratory test results adhering to recognized standards (ASTM D-5250-06e1, ASTM D-6124-06) and regulatory requirements (FDA 1000 ml. Water Fill Test, biocompatibility assessments). It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense. It's the inherent physical and chemical properties of the glove.

8. The Sample Size for the Training Set

• This is not applicable. The device is a physical medical product (examination gloves) that undergoes testing based on established standards, not a machine learning model that requires a "training set."

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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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 contamingtion between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a 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, Powder Free Vinyl Synthetic Examination Gloves with Aloe Vert Creen Color, 80 LYZ, and meets all requirements of ASTM standard D-5250-00E4.

The provided text describes a 510(k) summary for "Ever Light Plastic Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." This document is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a study in the way one would for diagnostic or therapeutic devices.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable in this context. This is a Class I medical device (patient examination glove), which typically requires demonstrating adherence to recognized standards and biocompatibility, not clinical performance studies with specific statistical metrics like sensitivity or specificity.

Here's a breakdown of the information that is available based on your request, highlighting where information is not applicable or not provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For ASTM-D-5250-00E4 (Physical & Dimensions): Inspection level S-2, AQL 4.0. (Specific number of gloves not stated, but defined by the inspection level and AQL for lot acceptance).
  • For FDA 1000 ml. Water Fill Test: Sampling AQL 2.5, inspection level I. (Specific number of gloves not stated, but defined by the inspection level and AQL for lot acceptance).
  • For Primary Skin Irritation and Skin Sensitization: Not specified (usually involves a number of human subjects or animal models, but specific count not provided).
  • For Residual Powder Test: Not specified (usually involves a number of gloves from a batch, but specific count not provided).
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). Given it's a device manufactured in China (Ever Light Products Co., Ltd. is based in Hebei, China), the testing would likely have been conducted by the manufacturer or a contracted lab to meet international and US standards. The studies described are non-clinical, related to product quality and safety characteristics, not clinical performance in a patient population.

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

• This is not applicable. The ground truth for these types of tests (physical properties, barrier integrity, biocompatibility) is established by the specifications of the ASTM standards and FDA test methods, not by expert consensus on clinical findings. For example, a pinhole is a physical hole, not an interpretation.

4. Adjudication Method for the Test Set

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for interpreting ambiguous clinical cases, often in diagnostic imaging. The tests described here have objective pass/fail criteria based on measured physical or chemical properties.

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

• No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). This document describes examination gloves, which do not involve human interpretation in this manner.

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

• No. This question is also not applicable as it pertains to AI/algorithm performance. The device is a physical product (gloves).

7. The Type of Ground Truth Used

• The ground truth used is based on objective standards and test methods:
  • ASTM Standard D-5250-00E4: Defines acceptable physical dimensions and properties.
  • FDA 1000 ml. Water Fill Test: Defines acceptable barrier integrity (absence of pinholes).
  • Primary Skin Irritation and Skin Sensitization testing protocols: Define methods and criteria for evaluating biocompatibility.
  • ASTM D-6124-01: Defines acceptable levels of residual powder.
  • Biocompatibility principles: Informed by scientific understanding of material interaction with the body.

8. The Sample Size for the Training Set

• This is not applicable. The device is not an AI/ML algorithm or diagnostic tool that requires a "training set." The testing described relates to quality control and meeting product standards.

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

• This is not applicable for the reasons stated in point 8.

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 disposable device intended for medical purposes 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, Powder Free Vinyl Patient Examination Glove, 801.YZ, and mects all requirements of ASTM Standard D5250-00 4.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves:

Device: Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Plasticizer EBN&BET

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific sample size not provided, but AQL 4.0 implies a statistically determined sample based on lot size).

• Freedom from Holes (Water Fill Test): Samplings of AQL 2.5, Inspection Level I. (Specific sample size not provided, but AQL 2.5 implies a statistically determined sample based on lot size).

• Primary Skin Irritation and Skin Sensitization: The text does not specify the sample size for these tests.

• Residual Powder Test: Not specified.

• Data Provenance: The tests were performed by the manufacturer, Grand Work Plastics Products Co., Ltd., presumably in P.R. China, where the company is located. The tests are "Non-Clinical tests," implying they were conducted in a laboratory or similar controlled environment. The data is retrospective in the sense that it was generated for the 510(k) submission.

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

• This device is a Class I medical device (patient examination glove) and the testing described is primarily laboratory-based performance testing and biocompatibility.
• No human experts were used to establish ground truth in the context of clinical interpretation or diagnosis. The ground truth for these tests is based on objective measurements against established ASTM standards and FDA requirements (e.g., water leak test, dimensional measurements, chemical analysis for powder, and animal/in vitro biocompatibility tests for skin irritation/sensitization).

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

• None. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving reader interpretation (e.g., radiology AI). This submission concerns a physical medical device and its performance against technical specifications and biocompatibility, not diagnostic accuracy requiring human reader adjudication. The results 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:

• No. This type of study (MRMC comparative effectiveness) is not applicable to an examination glove. It is primarily used for diagnostic devices, especially those incorporating AI, where human readers interpret medical images or data. The device in question is a physical barrier intended for infection control.

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

• Not applicable. This device is not an algorithm or AI-based system. It is a physical product.

7. The type of ground truth used:

• Objective measurements against established standards and laboratory test results.
  • For physical and dimensional testing: ASTM D5250-00 4.
  • For freedom from holes: FDA 1000ml. Water Fill Test based on ASTM D5151-99.
  • For biocompatibility (skin irritation and sensitization): Laboratory test results (the specific methods like ISO standards for biocompatibility are not explicitly cited but are implied by the "no primary skin irritant or sensitization reactions" statement).
  • For residual powder: ASTM D6124-01.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this product, as it is not an AI/machine learning device. The testing described focuses on product quality control and performance verification against established standards for manufacturing.

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

• Not applicable. As there is no training set, there is no ground truth established for one.

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 disposable device intended for medical purposes 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, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-00€4.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Grand Work Plastics Products Co., Ltd. Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies the following for the non-clinical tests:

• ASTM D5250-00€4 (Physical and Dimensions Testing): Inspection Level S-2, AQL 4.0. The exact sample size is not explicitly stated but is implicitly defined by the AQL (Acceptable Quality Level) and inspection level, which are statistical sampling plans.
• FDA 1000 ml. Water Fill Test based on ASTM D-5151-99: AQL 2.5, Inspection Level I. Again, the exact sample size is not explicitly stated but is defined by the AQL and inspection level.
• Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests is not provided in the document.
• Residual Powder Test: The sample size for this test is not provided.

Data Provenance: The tests were conducted by Grand Work Plastics Products Co., Ltd. in China. The data's provenance is therefore retrospective (tests conducted on manufactured products) and originates from China.

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

This information is not applicable as the device is a physical medical glove, and the "ground truth" for its performance is established through objective, standardized physical and chemical tests, not through expert human interpretation of data for diagnostic purposes.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. The tests have predefined pass/fail criteria based on accepted 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 AI devices where human readers interpret medical images or data. The device in question is a physical glove, not an AI-powered diagnostic tool.

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

No, a standalone study (in the context of an algorithm) was not done. This device is not an algorithm or AI product. Its performance is measured through direct laboratory testing.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Objective, Pre-defined Standards and Specifications: Specifically, ASTM D5250-00€4, ASTM D-5151-99, and ASTM D6124-01. These standards define the acceptable physical properties, barrier integrity (pinhole), and powder content.
• Biocompatibility Testing Protocols: Which assess the biological response to the material.

8. The Sample Size for the Training Set

This refers to the sample size of data used to train a machine learning model. Since the device is a physical product and not an AI/ML algorithm, a "training set" in this context is not applicable. The manufacturing process for the gloves would involve quality control and process validation, but this is distinct from an AI training set.

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

As there is no training set for an AI/ML algorithm associated with this device, this question is not applicable.

Ask a specific question about this device

A patient examination gloves is a disposable 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 Synthetic Examination Gloves, White Color (Sensi-Pro)

This document is a marketing authorization letter for Powder Free Vinyl Synthetic Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

A patient examination gloves is a disposable 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 Synthetic Examination Gloves, White Color (Sensi-Pro)

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for "Disposable Powder Free Vinyl Synthetic Examination Gloves White Color (Sensi-Pro)". It establishes the device's substantial equivalence to previously marketed devices and outlines regulatory compliance.

The document does not describe:

• Any acceptance criteria for device performance.
• Any study proving acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance, expert qualifications, or ground truth establishment.
• Any multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device

A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color

Unfortunately, the provided text is a letter from the FDA regarding the clearance of "Disposable Powder Free Vinyl Synthetic Examination Gloves, Green Color." It does not contain any information about acceptance criteria or a study that proves a device meets those criteria, as typically found in a scientific or performance evaluation report.

The letter is primarily focused on:

• Device Identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code.
• Regulatory Clearance: Stating that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.
• General Controls: Reminding the applicant of general regulations such as annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Contact Information: For regulatory advice.
• Indication for Use: A brief description of the intended use of the gloves.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information would be found in a separate performance study report or clinical trial documentation, not in an FDA clearance letter.

Ask a specific question about this device

Ask a specific question about this device

A Medical disposable gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Disposable Powder Free Vinyl Synthetic Examination Gloves, Beige color (Sensi-Pro)

The provided text is a 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Synthetic Examination Gloves, Beige Color (Brand Name: Sensi-Pro)". This document is a regulatory approval and does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other technical details requested in the prompt.

Therefore, I cannot provide the requested information based on the given input text.

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