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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

This document describes the acceptance criteria and the study conducted for "Cashmere Polymer Coated Powder Free Nitrile Examination Gloves".

1. Table of Acceptance Criteria and Reported Device Performance

Note: The asterisk () indicates average results from Attachment C, which is not provided in the given document.*

Study Details:

This document is a 510(k) summary for medical gloves, which are considered Class I devices. The studies performed are primarily bench tests and material characterization, aligning with the regulatory requirements for such devices. The concept of "AI" or "algorithms" does not apply to this type of device.

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

• The document implies that testing was conducted on samples of the manufactured gloves to ensure they meet the specified standards. However, the specific sample sizes for each test (e.g., number of gloves for watertight test, length, width, thickness, tensile strength, elongation, powder content, and biocompatibility) are not explicitly stated in the provided text.
• The data provenance is from Seal Polymer Industries Berhad, Malaysia, presumably from their internal testing facilities. The tests are described as performance data of gloves, which indicates a prospective testing approach on manufactured products.

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

• This is not applicable as the device is a physical medical glove. The "ground truth" is established by adherence to recognized industrial standards (ASTM D6319-00aE3) and FDA requirements, rather than expert interpretation of complex data like medical images. The tests involve objective measurements and established protocols.

4. Adjudication method for the test set:

• This is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic or imaging studies. For physical product testing, results are determined by direct measurement against quantitative 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:

• This is not applicable. This is a physical medical device (examination gloves), not an AI/software device involving human readers or interpretation of cases.

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

• This is not applicable. This is a physical medical device; there is no algorithm involved.

7. The type of ground truth used:

• The "ground truth" for the device's performance is based on established industrial standards (ASTM D6319-00aE3) and specific FDA requirements (e.g., watertight test, powder residual content, pinhole requirements, biocompatibility standards). These standards define the acceptable performance characteristics for patient examination gloves.

8. The sample size for the training set:

• This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI. The manufacturing process of the gloves would involve quality control and process validation, but not a "training set" in the computational sense.

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

• This is not applicable as there is no training set for this physical device.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA requirements.

This document describes the performance data for KOH2101, Powder Free Nitrile Examination Gloves, manufactured by SEAL Polymer Industries Berhad. The device is a Class 1 Nitrile Patient Examination Glove intended for medical purposes to prevent contamination between patients and examiners. The performance data is based on ASTM D6319-00a53 and FDA 1000 ml watertight test.

1. Table of Acceptance Criteria and Reported Device Performance:

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00a53 and FDA Water Leak Test.

The device being discussed is "Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Violet)". The study conducted to prove the device meets acceptance criteria is based on the performance data of the gloves according to ASTM D6319-00a3 standards and the FDA 1000 ml watertight test, as well as biocompatibility tests.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

• Indicates average results from Attachment B2, which is not provided in the document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test in the provided performance data. However, for the "Watertight (1000 ml)" test, an AQL (Acceptable Quality Level) of 2.5% is mentioned, which implies a sampling plan was used according to ASTM D6319-00a3.

The data provenance is from Malaysia, where Seal Polymer Industries SDN. BHD. is located. It is
prospective testing conducted by the manufacturer to demonstrate compliance with standards.

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 is not applicable as the device is a medical glove, and the "ground truth" is established by adherence to physical and chemical standards and biocompatibility tests, not subjective expert evaluation of medical images or conditions. The standards themselves (ASTM D6319-00a3 and FDA requirements) define the objective criteria.

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

Not applicable. The tests are objective measurements based on established standards, not subjective interpretations requiring 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 not an AI-enabled diagnostic device.

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

Not applicable. This is not an AI-enabled diagnostic device. The performance data presented refers to the physical and chemical properties of the glove itself.

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

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

• ASTM D6319-00a3 Standard: Defines the physical properties and performance requirements for nitrile examination gloves.
• FDA 1000 ml watertight test: A specific regulatory requirement for barrier integrity.
• FDA minimum powder residual content: A specific regulatory limit for powder on gloves.
• Biocompatibility test results: Objective laboratory tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) to assess the material's interaction with biological systems.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The manufacturing process for gloves is subject to quality control and batch testing, rather than an AI training paradigm.

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

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

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Latex Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-01 and FDA Water Leak Test.

The provided document describes the performance data for "Cashmere Powder Free Latex Examination Gloves" based on ASTM D3578-01 and FDA 1000 ml watertight test.

Here's an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

* The document states these are "The average result taken from Attachment B2," which is not included in the provided text.

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

The document does not explicitly state the sample sizes used for each test. However, it mentions "AQL=4.0%" for the watertight test, which refers to Acceptable Quality Level, a sampling standard. The data provenance is Malaysia and the study appears to be a prospective testing of manufactured gloves.

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

Not applicable. This is a physical device performance test based on established ASTM standards, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements against predefined 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

Not applicable. This is not an AI-assisted diagnostic device.

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

This is a standalone device in the sense that its performance is measured directly against physical and chemical standards, without human interaction with an algorithm.

7. The type of ground truth used

The ground truth is established by the specified ASTM D3578-01 Standard and FDA requirements for watertightness, powder content, and protein content. These are objective, quantitative standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set in that context. The "training" for the device would be the manufacturing process itself, and the goal is to consistently produce gloves that meet the specifications.

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

Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm. For the manufacturing process, the "ground truth" for the processes (making the gloves) is the ability to consistently achieve the stated performance criteria for the final product.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-00a and FDA Water Leak Test.

The provided document describes the acceptance criteria and performance data for Cashmere Powder Free Latex Examination Gloves.

1. Acceptance Criteria and Reported Device Performance

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

The document specifies "GI AQL=4.0%" for the watertight test, which refers to General Inspection Level 1 with an Acceptance Quality Limit of 4.0% according to ASTM D3578-00a. This standard typically involves sampling plans where the sample size is determined by the lot size, but the exact number of units tested is not explicitly stated in the provided text.

The data provenance is from Malaysia, specifically from SEAL POLYMER INDUSTRIES SDN. BHD. The study appears to be prospective as it involves the testing of a manufactured product against established standards.

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 document describes performance testing of a physical product (gloves) against established engineering and material standards (ASTM D3578-00a and FDA requirements), not the establishment of ground truth by human experts for a diagnostic algorithm.

4. Adjudication method for the test set

This information is not applicable as the document describes performance testing of a physical product against established objective standards, not a process requiring 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

This information is not applicable as the document describes the performance of a physical medical device (examination gloves) and does not involve AI, human readers, or case studies.

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

This information is not applicable as the document pertains to the performance of a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used consists of established industry standards and regulatory requirements:

• ASTM D3578-00a Standard for Latex Examination Gloves
• FDA Water Leak Test requirements (1000 ml watertight test)
• FDA minimum powder residual content requirements
• Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test)

8. The sample size for the training set

This information is not applicable. The document describes the performance of a physical product, not a statistical model or algorithm that requires a training set.

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

This information is not applicable as there is no training set mentioned or implied for this physical product performance testing.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, -.

Class 1 Nitrile Patient Examination Glove 80LZA, powder free that meets all the requirements of ASTM Standard D6319-00 and FDA Water Leak Test.

The provided document describes the acceptance criteria and study for "Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (White)".

Description of the Device and Intended Use:
The device is a Class 1 Nitrile Patient Examination Glove, powder-free, intended to be worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste, or environment.

Acceptance Criteria and Reported Device Performance:

Study Information:

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

   • The document does not specify the exact sample sizes for each test mentioned in the table. It refers to "GI AQL=2.5%" for the watertight test, which indicates a sampling plan based on Acceptance Quality Limit, but not the specific number of gloves tested.
   • Data Provenance: The studies were conducted by SEAL POLYMER INDUSTRIES SDN. BHD. in Malaysia. The nature of the tests (physical property measurements, watertight tests, biocompatibility) implies prospective testing on manufactured gloves.

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

   • This is not applicable as the studies are technical performance tests against established standards (ASTM D6319-00, FDA requirements) and not diagnostic or interpretive tasks requiring expert ground truth establishment.

3. Adjudication method for the test set:

   • Not applicable for these types of performance tests. The results are objective measurements against defined minimums or ranges.

4. 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, a multi-reader multi-case comparative effectiveness study was not done. This type of study is not relevant for the performance evaluation of examination gloves, which are physical medical devices.

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

   • Not applicable. The device is a physical glove, not an algorithm.

6. The type of ground truth used:

   • The "ground truth" for the performance tests consists of established industry standards and regulatory requirements:
     • ASTM D6319-00 Standard for Nitrile Patient Examination Gloves.
     • FDA 1000 ml watertight test requirements.
     • FDA minimum powder residual content requirements.
   • For the biocompatibility tests, the ground truth is "Pass" based on established biological safety evaluation methods (Primary Dermal Irritation Test and Guinea Pig Sensitization test).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

8. 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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A medical glove 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.

Class 1 Powdered Latex Patient Examination Glove 80 LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-99 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance data for "Cashmere Non-Sterile, Powdered Latex Examination Gloves". Here's the information requested, extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states these figures were the average among the eight tested samples.

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

• Sample Size for Test Set: The document explicitly mentions "eight tested samples" for the physical properties (tensile strength and ultimate elongation). For watertightness, it references "GI AQL=2.5%", which implies a sampling plan defined by ASTM D3578-99 and FDA 1000 ml watertight test, but the specific number of gloves tested is not provided in this summary.
• Data Provenance: The study appears to be retrospective, as it's a summary of performance data collected to demonstrate compliance with existing standards (ASTM D3578-99 and FDA requirements). The manufacturer is Seal Polymer Industries Sdn. Bhd., located in Lahat, Perak, Malaysia.

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

Not applicable. This is a performance claim for a physical device based on standardized tests, not an AI/diagnostic device requiring expert ground truth establishment for medical image interpretation or similar. The "ground truth" is established by the specifications in ASTM D3578-99 and FDA requirements.

4. Adjudication method for the test set

Not applicable. As this involves physical testing against established standards, adjudication by experts for discordant results is not mentioned or typically relevant. The results are objective measurements or pass/fail criteria.

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 document describes a medical glove, not an AI-assisted diagnostic device.

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

Not applicable. This document describes a medical glove, not an algorithm.

7. The type of ground truth used

The ground truth for this device's performance is based on established industry standards and regulatory requirements:

• ASTM D3578-99 Standard
• FDA 1000 ml watertight test requirements
• FDA minimum powder residual content requirements
• Biocompatibility test standards (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buchler) test).

8. The sample size for the training set

Not applicable. This is a medical glove, not an AI device that requires a training set.

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

Not applicable. This is a medical glove, not an AI device that requires a training set.

Ask a specific question about this device

This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.

Class 1 Nitrile Patient Examination Glove 80 LZA, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.

This document describes the acceptance criteria and performance of the Cashmere Non-Sterile, Powder Free Nitrile Examination Gloves (Blue and Green).

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 explicitly state the specific sample sizes used for each test. However, the performance data is based on the ASTM D3578-95 standard and the FDA 1000 ml watertight test, which would typically specify sampling plans. The data provenance is from SEAL POLYMER INDUSTRIES SDN. BHD. in Lahat, Perak, Malaysia. The study appears to be a retrospective analysis of product performance against established standards.

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

This information is not provided in the document. For product performance testing against standard specifications like ASTM D3578-95, the "ground truth" is typically defined by the objective measurement procedures within the standard, not by expert consensus on individual cases.

4. Adjudication method for the test set:

Not applicable. The performance data is based on objective measurements and compliance with a standard (ASTM D3578-95) and FDA requirements, not on subjective interpretations requiring 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 submission for a medical glove, a physical device, and not an AI-powered diagnostic or decision support tool that would involve human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth used for performance evaluation is based on established industry standards and regulatory requirements, specifically:

• ASTM D3578-95 Standard for Rubber Examination Gloves.
• FDA 1000 ml watertight test for pinhole requirements.
• FDA requirements for minimum powder residual content.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. This is a physical medical device.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.

Class 1 Polymer Coated Patient Examination Glove 80 LYY, powder free that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.

The provided documentation describes the acceptance criteria and performance of the "Cashmere Non-Sterile, Polymer Coated Powder Free Latex Examination Gloves." This is a Class I medical device, and the evaluation is based on established ASTM standards and FDA requirements for such gloves, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., test set sample size, expert ground truth, MRMC study, standalone performance, training set) are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that performance data is based on "ASTM D3578-95 and FDA 1000 ml watertight test." These standards specify sampling plans (e.g., AQL for watertightness), but the exact sample sizes used for this specific submission are not explicitly provided in the excerpt. The data provenance is for a manufacturing company located in Malaysia (SEAL POLYMER INDUSTRIES SDN. BHD., Lot 72706, Jalan Lahat, Kawasan Perindustrian Bukit Merah, 31500 Lahat, Perak, Malaysia). The nature of these tests (physical and chemical properties) indicates a prospective evaluation of manufactured samples.

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

Not applicable. This is a medical glove, and its performance is evaluated against objective physical and chemical standards (ASTM D3578-95, FDA watertight test). It does not involve expert interpretation or ground truth establishment in the context of diagnostic AI/ML devices.

4. Adjudication method for the test set

Not applicable. Device performance is measured against quantifiable standards for physical and chemical properties.

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/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device's performance is objective measurement against established industry and regulatory standards. For example, for "Watertightness," the ground truth is whether the glove passes the FDA's 1000 ml watertight test at an AQL of 4.0%. For dimensions, it's the measured length and width compared to the specified range. For physical properties, it's the measured tensile strength and elongation compared to minimum requirements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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This is a medical glove to be worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patients' body, fluids, waste or environment.

Class 1 Nitrile Patient Examination Glove 80 LZA, powdered with absorbable dusting powder, that meets all the requirements of ASTM Standard D3578-95 and FDA Water Leak Test.

The provided text describes the acceptance criteria and performance of "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Blue)" and "Cashmere Non-Sterile, Powdered Nitrile Examination Gloves (Green)" as detailed in the K993133 510(k) submission.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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