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Powder Free Nitrile Examination Gloves, Blue, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

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

Device: Powder Free Nitrile Examination Gloves, Blue, Non-Sterile

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that the device "meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test" (Section 5.0 and 10.0), which are foundational for examination gloves.

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

• Sample Size: Not explicitly stated in the provided text. The document refers to "performance test data of the non-clinical tests" but does not give specific sample sizes for each characteristic.
• Data Provenance: The device manufacturer (PT. WRP Buana Multicorpora) is based in Indonesia. The testing standards mentioned (ASTM, FDA) are international/US standards, implying the testing was conducted to these requirements. The text does not specify the country of origin of the data collection beyond the manufacturer's location. The studies are described as "non-clinical tests." It is a prospective study as the data supports a premarket notification for a new device.

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

• Not applicable as this is a non-clinical device (examination glove) and the testing involves physical and chemical property assessments rather than expert interpretation of medical images or patient conditions. The "ground truth" is established by adherence to defined ASTM and FDA engineering/testing standards.

4. Adjudication method for the test set:

• Not applicable for this type of non-clinical device testing. The results are based on objective measurements against established 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:

• Not applicable. This is not a software algorithm or AI device. The "standalone" performance refers to the intrinsic properties of the physical glove itself, tested against established standards.

7. The type of ground truth used:

• For Dimensions, Physical Properties, Freedom from Pinholes, and Powder Free Residue: The ground truth is defined by established engineering and material testing standards (ASTM D 6319-00ae3, FDA 21 CFR 800.20, FDA 1000 ml Water Leak Test, ASTM D 6124-01). The device passes or fails based on objective measurements against these predefined thresholds.
• For Biocompatibility (Primary Skin Irritation and Dermal Sensitization): The ground truth is established through pre-clinical animal testing (specifically in Rabbits for skin irritation). The "Passes" outcome indicates no adverse biological reaction following standard protocols.

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. This is not an AI/machine learning device.

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Powder Free White Nitrile Examination Gloves, Non-Sterile is a disposable device and made of Synthetic Rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free White Nitrile Examination Gloves, Non sterile meets all the requirements of ASTM standard D 6319 – 00a83 and FDA 1000 ml Water Leak Test.

This document describes the acceptance criteria and performance of Powder Free White Nitrile Examination Gloves, Non-Sterile.

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 sample sizes used for each test. The tests are based on ASTM standards (D 6319 – 00ae3, D 6124 – 01) and FDA regulations (21 CFR 800.20, FDA 1000 ml Water Leak Test). These are standard test methods and it can be inferred that samples were taken from manufactured batches for testing. The data provenance is not specified beyond indicating compliance with US standards. It is implied to be prospective testing for product qualification.

3. 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 acceptance criteria are based on standardized laboratory tests and regulatory requirements, not on expert consensus or interpretation of medical images.

4. Adjudication method for the test set:

   This is not applicable. The tests involve objective measurements against predefined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   No, a multi-reader multi-case comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., AI in radiology), not for physical medical devices like examination gloves.

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

   This is not applicable. This refers to an "algorithm only" performance, which is relevant for AI/software as a medical device, not for the physical examination gloves described.

7. The type of ground truth used:

   The ground truth is based on established scientific and regulatory standards. For example:

   • Dimensions, Physical Properties, Freedom from Pinholes: Objectively measured against the requirements specified in ASTM D 6319 – 00ae3 and FDA 21 CFR 800.20.
   • Powder Free Residue: Objectively measured against the requirements of ASTM D 6124 - 01.
   • Biocompatibility: In-vivo animal tests (Primary Skin Irritation in Rabbits, Dermal Sensitization tests) with predefined pass/fail criteria.

8. The sample size for the training set:

   This is not applicable. There is no mention of a "training set" as this device is a physical product and its performance is evaluated through direct testing against predetermined standards, not through machine learning or AI models that require training data.

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

   This is not applicable, as there is no training set for this type of device.

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Powder Free Latex Examination Gloves, Blue, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free Latex Examination Gloves, Blue, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

The provided text describes the acceptance criteria and performance of Powder Free Latex Examination Gloves. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to meeting standards such as ASTM D 3578 - 01aᵉ² and FDA 1000 ml Water Leak Test, which would imply specific sampling plans as defined within those standards, but the exact number of gloves tested is not provided in this summary.
• Data Provenance: The testing was conducted by PT. WRP Buana Multicorpora, an Indonesian company. The data is retrospective in the sense that it's a summary of tests performed to demonstrate compliance with existing standards for a 510(k) submission.

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

• This type of information is not applicable to the evaluation of examination gloves. The "ground truth" for glove performance refers to meeting established physical, chemical, and biological standards (e.g., tensile strength, protein content, freedom from pinholes, biocompatibility). These are measured objectively by laboratory methods against defined criteria, not through expert consensus or interpretation.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or evaluations where subjective assessments (e.g., image interpretation) require consensus among multiple experts. Glove testing involves objective measurements against predetermined 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-enabled device or a diagnostic imaging device requiring human reader 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 (examination gloves), not a software algorithm.

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

• The "ground truth" for the device's performance is based on objective measurements against established national and international standards. These include:
  • ASTM D 3578 - 01aᵉ² (Standard Specification for Rubber Examination Gloves) for dimensions, physical properties, and freedom from pinholes.
  • FDA 21 CFR 800.20 (Barriers with an Integral Safety Shield or Feature) and the 1000 ml Water Leak Test for freedom from pinholes.
  • ASTM D 6124 - 01 (Standard Test Method for Residual Powder on Medical Gloves) for powder residue.
  • ASTM D 5712 - 99 (Standard Test Method for Analysis of Aqueous Extractable Protein in Latex and Natural Rubber) for water soluble protein content.
  • Biocompatibility tests (Primary Skin Irritation in Rabbits, Dermal Sensitization), which involve standardized animal models or in-vitro tests with defined pass/fail criteria.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device 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 device.

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Latex Examination Gloves, Powdered, Blue, Non-Sterile is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Latex Examination Gloves, Powdered, Blue, Non Sterile meets all the requirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Test.

The provided document describes the acceptance criteria and performance of PT. WRP Buana Multicorpora's Latex Examination Gloves, Powdered, Blue, Non-Sterile.

Here's an analysis based on your request:

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 the exact sample size used for each "test set" (batch of gloves tested to demonstrate compliance). However, it implies that the tests were conducted on batches of the device to ensure they "Meet" the specified standards.

• Data Provenance: The tests were conducted by PT. WRP Buana Multicorpora, an Indonesian company. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate compliance with existing 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 device performance testing of physical/chemical characteristics and biocompatibility, specialized laboratory testing and interpretation by appropriately qualified lab personnel are typically involved, but "experts" in the sense of medical professionals adjudicating diagnostic results are not relevant here.

4. Adjudication method for the test set

This information is not applicable/provided as the tests relate to objective physical, chemical, and biological properties of the glove, which are likely evaluated against predefined thresholds in the ASTM standards. There is no mention of a subjective adjudication process by multiple individuals.

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 product (examination gloves), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related comparative effectiveness is irrelevant to its evaluation.

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

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

7. The type of ground truth used

The "ground truth" for the device's performance is based on defined standards set by ASTM (American Society for Testing and Materials) and FDA regulations. For example:

• Physical properties and dimensions: Defined by ASTM D 3578 – 01ae2.
• Freedom from pinholes: Defined by ASTM D 3578 - 01ae2 and FDA 21 CFR 800.20 (specifically, the 1000 ml Water Leak Test).
• Powder amount and Water Soluble Protein Content: Defined by specific ASTM standards (D 6124 - 01 and D 5712 - 99, respectively).
• Biocompatibility: Assessed using standard animal models (Primary Skin Irritation in Rabbits and Dermal Sensitization tests) with established criteria for "passes."

8. The sample size for the training set

Not applicable. This refers to a manufactured product and not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As above, there is no "training set" for this type of device. The ground truth for evaluating the device's compliance is established by the specified industry and regulatory standards.

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The Powder Free Latex Examination Gloves, Non-Sterile (Protein Content Labeling 50 µg/g or less) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling 50 ug/q or less) is Class I Device, Code No. 80LYY. These gloves are made of natural rubber latex. Based on the protein content test result obtained the aloves are well bellow 50 ug/g and support our protein content labeling claim.

The provided text describes a 510(k) summary for "Glovetex Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50ug/g or less)". This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study on a new device's performance against detailed acceptance criteria for an AI/algorithm.

The "acceptance criteria" and "device performance" in this context refer to the physical and chemical properties of the gloves themselves, compared against established standards for examination gloves and the specific protein content claim. The "study" described is the testing conducted on the gloves to demonstrate conformance to these standards and the protein content claim.

Here's an attempt to structure the information based on the provided request, interpreting "acceptance criteria" and "device performance" in the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for each specific test (e.g., protein content, ASTM D 3578, water leak test). It generally states that "The result of the performance testing... are detailed in this submission."

• Sample Size: Not explicitly stated for the test set of gloves.
• Data Provenance: The manufacturing company is PT. WRP Buana Multicorpora, located in Indonesia. The testing would have been conducted by or for this manufacturer. The document doesn't specify if the data is retrospective or prospective, but performance testing for a 510(k) submission typically involves prospective testing of production samples.

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

This type of information (number of experts, their qualifications, and ground truth establishment) is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis). For the physical and chemical testing of examination gloves, "ground truth" is established by laboratory measurements and adherence to specified testing protocols (e.g., ASTM standards). Therefore, this question is not directly applicable in the conventional sense to this device. The "experts" would be qualified laboratory technicians or engineers performing the tests.

4. Adjudication Method for the Test Set

Again, adjudication methods like 2+1 or 3+1 are primarily used for reaching consensus among multiple human reviewers/experts, particularly in studies involving subjective interpretation. For objective laboratory tests on gloves, adjudication is not typically performed in this manner. The results are based on direct measurement and comparison to predefined thresholds.

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 evaluating diagnostic or interpretive devices (e.g., AI in radiology) where human readers are involved. This submission is for physical examination gloves.

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

No, this pertains to a physical medical device (examination gloves), not an algorithm or AI. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these gloves is based on:

• Laboratory Testing Results: Direct measurements of physical properties (e.g., water leak test) and chemical properties (e.g., protein content determination).
• Adherence to Established Standards: Conformance to recognized industry standards such as ASTM D 3578.

8. The Sample Size for the Training Set

This question is 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

This question is not applicable, as there is no training set for this device.

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The gloves are intended to be worn on the hand of healthcare personnel and similar personnel to prevent contamination between the healthcare or similar personnel and also can be used to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste or environment.

The Examination Glove is a medical glove which is disposable device intended for medical purposes that is wom on the examiner's hand or finger to prevent contamination between examiner and patient.

Class I Latex Patient Examination Glove 80 LYY, protein content labeling, that meets all of the requirements of the ASTM Standard D3578-99.

The document describes the acceptance criteria and performance data for "Glovetex Examination Gloves, Powdered Non-Sterile (Protein Content Labeling)".

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The document describes a study based on "Performance data of gloves to ASTM D 3578-99 and FDA 1000 ml Watertight Test." and "Protein content tested on recently manufactured and accelerated ageing gloves using ASTM D 5712 — 95".

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

• The document does not specify the exact sample size used for the various tests. However, it refers to AQL (Acceptable Quality Level) values for Watertight (AQL 1.5) and Physical Properties (AQL 4.0), which are statistical sampling plans used in quality control. This implies that a sufficient sample size was tested to determine compliance with these AQLs.
• Data Provenance: The manufacturing company is listed as PT. WRP Buana Multicorpora in Medan-Labuhan Km 17, INDONESIA. The raw data would originate from their in-house testing facilities in Indonesia. The testing itself is retrospective, as it's a summary of performance data collected after manufacturing for the purpose of regulatory submission.

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 information is not applicable as the document describes performance testing for medical gloves, which relies on standardized physical and chemical tests rather than expert interpretation of medical images or conditions. The "ground truth" here is the objective measurement against the specified ASTM standards and in-house criteria.

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

• This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation (e.g., medical image reading) where multiple experts might disagree. For the physical and chemical testing of gloves, objective measurements are taken against predefined criteria, and thus, no expert adjudication is required.

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 described is an examination glove, which is a physical product, not an AI-assisted diagnostic tool or an imaging device. Therefore, an MRMC study is not relevant.

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, not an algorithm.

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

• The ground truth used for this study is based on objective measurements against established industry standards (ASTM D 3578-99, ASTM D 5712-95) and the manufacturer's in-house specifications. This includes physical properties (e.g., tensile strength, elongation, dimensions), chemical properties (e.g., protein content, powder content, moisture content), and performance characteristics (e.g., watertightness).

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of testing a physical medical device like an examination glove. The performance data presented are results from testing a manufactured product against predefined specifications.

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

• This information is not applicable as there is no training set for this type of device testing.

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