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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 containation 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, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all 21 C requirements of ASTM standard D-5250-00E4.

This document describes the 510(k) summary for Super Safe Plastic Products Co., Ltd.'s Powdered Vinyl Patient Examination Gloves, White. The summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides the following information:

• ASTM D-5250-00E4 (Physical & Dimensions): "Inspection level S-2, AQL 4.0." This refers to sampling plans defined within the ASTM standard. The specific sample size is not explicitly stated in the provided text but would be determined by these parameters.
• FDA 1000 ml Water Fill Test (Pinhole): "Samplings of AQL 2.5, inspection level I." Similar to the above, this indicates the sampling plan, but the exact numerical sample size is not presented.
• Primary Skin Irritation and Skin Sensitization: The document doesn't specify sample sizes for these tests.
• Residual Powder Test: The document doesn't specify sample size for this test.

Data Provenance: Not explicitly stated, but based on the manufacturer's location (Shijiazhuang, Hebei, China), the testing was likely conducted in China. The document does not specify if the data is retrospective or prospective.

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

Not applicable. The tests performed are objective, laboratory-based tests (e.g., physical measurements, water fill tests, chemical tests, biocompatibility tests). They do not involve expert interpretation or ground truth establishment in the way, for example, a diagnostic imaging study would.

4. Adjudication Method for the Test Set

Not applicable, as the tests are objective and do not require expert 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 is a medical device for personal protection (gloves), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its evaluation.

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 system.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

• Established ASTM Standards: For physical properties, dimensions, and residual powder content. These standards define objective criteria and test methods.
• FDA Requirements: For the pinhole test (1000 ml Water Fill Test).
• Biocompatibility Testing Protocols: For primary skin irritation and skin sensitization, which involve established biological assessment methods.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model and does not involve a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a series of non-clinical tests conducted on the Super Safe Plastic Products Co., Ltd. Powdered Vinyl Patient Examination Gloves, White. These tests were designed to demonstrate compliance with recognized industry standards and regulatory requirements for patient examination gloves.

The key aspects of this study include:

• Compliance with ASTM D-5250-00E4: The gloves were tested for physical and dimensional characteristics, with all results meeting the requirements of this ASTM standard. The sampling plan for these tests was based on "Inspection level S-2, AQL 4.0."
• Pinhole Integrity (FDA 1000 ml Water Fill Test): The gloves underwent the FDA 1000 ml Water Fill Test, meeting the requirements with a sampling plan of "AQL 2.5, inspection level I."
• Biocompatibility Testing:
  • Primary Skin Irritation: Tests were conducted, showing no primary skin irritant reactions.
  • Skin Sensitization (Allergic Contact Dermatitis): Tests were conducted, showing no sensitization reactions.
• Residual Powder Content: A Residual Powder Test based on ASTM D-6124-06 was performed to ensure the gloves meet the "powdered" claim, meaning they contain no more than 10mg/dm2 of starch.

The conclusions of these tests collectively demonstrated that the device "conform[s] fully to ASTM D-5250-00E4 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims." The results provided the basis for the FDA's determination of substantial equivalence to the predicate device.

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Powdered vinyl patient examination glove 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.

powdered vinyl patient examination gloves, white(non-colored) that mects all of the requirements of ASTM standard D 5250-0004.

1. Table of Acceptance Criteria and Reported Device Performance:

   Characteristics	Acceptance Criteria (Standard)	Reported Device Performance
   Dimension	ASTM standard D 5250-00c4	Meets
   Physical Properties	ASTM standard D 5250-00c4	Meets
   Freedom from pinholes	21 CFR 800.20	Meets
   Powder Amount	ASTM standard D 5250-00c4	Meets
   Biocompatibility (extract.)	Not specified (implied <10mg/dm2)	<10mg/dm2
   Primary Skin Irritation	ISO10993-10	Passes
   Dermal Sensitization	ISO10993-10	Passes

2. Sample size used for the test set and the data provenance:
   The document does not specify the exact sample sizes used for testing each characteristic. The data provenance is not explicitly stated in terms of country of origin, but the testing was performed to ASTM and ISO standards, and CFR regulations, implying an adherence to internationally recognized testing procedures. The study appears to be non-clinical, involving testing of the physical and chemical properties of the gloves, rather than human clinical trials. It is a prospective evaluation against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This section is not applicable as the "ground truth" for this device (a patient examination glove) is established by performance against pre-defined engineering and safety standards (e.g., ASTM, ISO, CFR), not by expert medical interpretation or diagnosis.

4. Adjudication method for the test set:
   Not applicable. The performance is assessed against objective technical standards, not through adjudication of expert opinions.

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 device (examination gloves), not an AI-assisted diagnostic or interpretative tool. Therefore, MRMC studies and AI-related effectiveness are not relevant.

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

7. The type of ground truth used:
   The ground truth for this device is based on established industry standards and regulatory requirements for medical devices, specifically for patient examination gloves. These include:

   • ASTM standard D 5250-00c4 (for dimensions, physical properties, powder amount)
   • 21 CFR 800.20 (for freedom from pinholes)
   • ISO10993-10 (for biocompatibility, including primary skin irritation and dermal sensitization)

8. The sample size for the training set:
   Not applicable. As this is a physical medical device and not a machine learning model, there is no "training set" in the conventional sense. The manufacturing process is likely subject to quality control and sampling for ongoing compliance.

9. How the ground truth for the training set was established:
   Not applicable. No training set is used for this type of device.

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Powdered vinyl patient examination glove 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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00-4

Here's an analysis of the provided text regarding acceptance criteria and study information for the "Powdered Vinyl Patient Examination Gloves, White (Non-colored)":

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 the specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals for biocompatibility). However, the tests are conducted in accordance with referenced standards (ASTM D 5250-00c4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards typically specify sample sizes or methodologies for such testing.

The data provenance is not specified beyond "Hebei Manful Import & Export Co., Ltd." as the submitter, located in China. The studies are non-clinical (laboratory testing) and are retrospective in the sense that they were completed before the 510(k) submission.

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

This information is not provided. For non-clinical, objective performance tests like those conducted for examination gloves (dimensional, physical properties, pinholes, powder amount), the "ground truth" is typically established by laboratory measurements against defined standards, rather than expert consensus on subjective findings. For biocompatibility, the ground truth is established by the observed biological response in animal models, interpreted by qualified toxicologists or study directors, though their number and specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

Not applicable for these types of non-clinical performance and biocompatibility studies. The results are typically objective measurements or observations against predefined pass/fail criteria according to the referenced standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. Examination gloves are medical devices with objective performance criteria.

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

Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against the specified standards without human interaction influencing the device's function or interpretation of its output. The device itself (the glove) is not an algorithm, so "algorithm only" is not directly applicable. However, its physical characteristics and biological safety were tested in an isolated manner.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Defined Standards: For dimensions, physical properties, powder amount, and freedom from pinholes, the "ground truth" is adherence to the specified ASTM and CFR standards with their quantitative limits.
• Laboratory Observations/Measurements: For biocompatibility, the ground truth is established through observed biological responses in animal models (e.g., presence or absence of irritation or sensitization), as interpreted by testing personnel/toxicologists following the ISO standard.

8. Sample Size for the Training Set

Not applicable. This device is an examination glove, not an AI/ML algorithm or a device that requires a "training set" in the context of machine learning. The studies described are performance and safety tests, not algorithm training.

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

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

Ask a specific question about this device

Powdered vinyl patient examination glove 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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-0004

The provided document describes the safety and effectiveness information for "Powdered Vinyl Patient Examination Gloves, White (Non-colored)" submitted by ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD. The study presented is a non-clinical evaluation comparing the device's technical characteristics against established standards.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the specific sample size for each characteristic test (e.g., how many gloves were tested for dimensions, pinholes, etc.). It generally refers to meeting the requirements "per ASTM D5250-00", "per ASTM D6124-01", "per 21 CFR 800.20", and "ISO10993-10". These standards would define the required sample sizes for such tests.
• Data Provenance: The data is presented as a summary of non-clinical tests performed by the manufacturer, ZIBO ZHUANGYUAN PLASTIC & RUBBER CO.,LTD, located in China. The testing appears to be retrospective in nature, as it's a submission for regulatory review based on already conducted tests. The country of origin of the data is P.R.CHINA.

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

• This device is a Class I medical device (patient examination gloves). The "ground truth" for its performance is established by adherence to recognized industry standards (ASTM, FDA regulations, ISO) rather than expert consensus on individual cases.
• Therefore, there were no specific "experts" in the sense of medical professionals diagnosing conditions being used to establish a ground truth for individual items in the test set. The ground truth is the standard's specification itself, and the testing laboratories or personnel would be qualified to perform the tests according to those standards.

4. Adjudication Method for the Test Set:

• Not applicable in the context of this device and study. The evaluation focuses on meeting predefined specifications from industrial standards, not on subjective interpretations requiring adjudication.

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 where human readers interpret images or data, and AI assistance is being evaluated. Patient examination gloves do not involve human readers interpreting data in this manner.

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

• Yes, in spirit, the study is standalone. The device itself (the glove) is evaluated against objective, measurable criteria defined by standards. There is no "algorithm" in a software sense, but the device's physical and biological properties are assessed in a standalone manner without human intervention influencing the outcome of the measurement beyond the testing procedure itself. The performance "meets" or "passes" the specified criteria.

7. The Type of Ground Truth Used:

• The ground truth used is primarily objective, established performance criteria and requirements defined by international and national standards (ASTM standard D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10). These standards specify acceptable ranges for dimensions, physical properties, pinhole rates, powder amount, and biocompatibility outcomes.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device being tested against established standards, not a machine learning algorithm that requires a "training set."

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

• Not applicable, as there is no training set for this type of device evaluation.

Ask a specific question about this device

Powdered vinyl patient examination glove 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.

powdered vinyl patient examination gloves, white(non-colored) that meets all of the requirements of ASTM standard D 5250-00c4

The provided text describes the regulatory submission for Powdered Vinyl Patient Examination Gloves. It details the device's characteristics and its equivalence to a predicate device, primarily through adherence to established standards.

Here's an analysis of the acceptance criteria and the study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" sample size in the context of typical AI/software performance studies. The testing described pertains to physical and biological properties of the gloves, and the sample sizes for these tests are not explicitly stated. The data provenance is internal testing by the manufacturer, SHIJIAZHUANG WINFUL PLASTIC CO.,LTD, located in China. The studies are by nature retrospective as they are conducted on manufactured products to ensure compliance.

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 as the device is a physical medical device (examination gloves), not an AI/software device requiring expert interpretation of data to establish ground truth for a test set. The "ground truth" for the device's performance is objective measurements against established ASTM and CFR standards, as performed by laboratory testing.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. No adjudication method is described for determining the "ground truth" of the physical and biological characteristics of the gloves.

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 information is not applicable. The device is an examination glove, not an AI/software device that would involve human readers or AI assistance.

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

This information is not applicable. The device is an examination glove, and there is no algorithm or human-in-the-loop involved in its function or evaluation.

7. The type of ground truth used

The ground truth used for evaluating the device is based on objective measurement against established regulatory and industry standards. Specifically:

• ASTM standard D 5250-00e4 for dimensions, physical properties, and powder amount.
• 21 CFR 800.20 for freedom from pinholes (waterleak test).
• ISO 10993-10 for biocompatibility (Primary Skin Irritation and Dermal sensitization tests).

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this device, as it is a physical product and not an AI/machine learning model.

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

This information is not applicable for the same reasons as point 8.

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