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The patient examination glove is a disposable device and is made of natural The patient exammation grove is a 'displace' worn on the examiner's hand of furoer to prevent contamination between patient and examiner.

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 - 01aE2 and FDA 21 CFR 800.20.

The provided text describes a 510(k) summary for "Powder Free Latex Examination Gloves Coated with Vitamin E, and with Protein Content Labeling Claim". This is a medical device application for examination gloves, which falls under a different category than typical AI/ML medical devices that require the types of studies listed in the prompt.

Therefore, many of the requested elements are not applicable to this 510(k) submission. Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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 specify sample sizes for each test listed in the characteristics table.
• The data provenance is not explicitly stated as country of origin, but the submitting company is WRP Specialty Products Sdn Bhd from Malaysia. The tests refer to ASTM and FDA standards, which are international/US standards. The nature of these tests (e.g., physical properties, chemical analysis) generally implies laboratory testing rather than data from human patients or retrospective studies in the way an AI/ML device would.

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

• Not applicable. The ground truth for these device characteristics is established by scientific methodologies and standardized test procedures (e.g., ASTM standards, chemical analysis), not by expert consensus in the clinical sense.

4. Adjudication method for the test set

• Not applicable. The "adjudication method" as typically understood for clinical studies (e.g., 2+1, 3+1) is not relevant for laboratory and performance testing of physical devices like 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

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

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

• Not applicable. This is not an algorithmic device.

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

• The "ground truth" for this device is based on standardized laboratory testing and analytical methods as defined by ASTM and FDA regulations. For example:
  • Dimensions: Measured against specified tolerances in ASTM D 3578 - 01aE2.
  • Physical Properties: Tested according to ASTM D 3578 - 01aE2 protocols.
  • Freedom from pinholes: Tested using water leak methods as per ASTM D 3578 - 01aE2 and FDA 21 CFR 800.20 (AQL).
  • Powder-Free: Measured using gravimetric methods as per ASTM D 6124 - 01.
  • Protein Level: Measured using chemical assay methods as per ASTM D 5712 - 95.
  • Biocompatibility: Tested on rabbits (Primary Skin Irritation) and humans (Dermal Sensitization) using established toxicology protocols.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of AI/ML.

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

• Not applicable. There is no training set for this type of device.

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The 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.

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less) meets all the requirements of ASTM standard D 3578 -- 01a"22 and FDA 21.CFR 800.20.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Micrograms or less)":

It's important to note that this 510(k) summary is for a medical device (gloves), not an AI algorithm. Therefore, many of the typical questions related to AI studies (like sample size for test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, or training set details) are not applicable or not provided in this type of submission.

The document primarily focuses on demonstrating that the gloves meet established industry standards and regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated. For medical devices like gloves, testing is typically done on batches, and samples are drawn from these batches according to industrial standards (e.g., AQL levels for pinholes). The document refers to meeting ASTM standards, which would implicitly define the sampling methods and sizes.
• Data Provenance: Not specified, but likely from internal testing conducted by WRP Specialty Products Sdn Bhd in Malaysia, given the submitter's location. The biocompatibility tests would generally be conducted by specialized laboratories.
• Retrospective or Prospective: Not applicable in the context of device performance testing against standards. The tests are performed on newly manufactured devices.

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

• Not Applicable. For medical devices like gloves, "ground truth" is defined by established scientific and engineering standards (e.g., ASTM standards for glove properties, FDA regulations for pinholes, established biological assays for biocompatibility). There isn't a panel of clinical experts establishing ground truth in the same way they would for diagnostic imaging.

4. Adjudication method for the test set:

• Not Applicable. Performance is assessed against quantitative metrics and established pass/fail criteria from the standards, not through adjudication by multiple human observers.

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 is not relevant for the assessment of a medical device like examination gloves. MRMC studies are typically for diagnostic AI algorithms where human interpretation is involved.

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

• Not Applicable. This is not an AI algorithm; it's a physical medical device.

7. The type of ground truth used:

• The "ground truth" is based on established industry standards and regulatory requirements.
  • ASTM D 3578 01aE2: Standard Specification for Rubber Examination Gloves.
  • FDA 21 CFR 800.20: Regulations for pinhole testing (water leak test).
  • ASTM D 6124 01: Standard Test Method for Residual Powder on Medical Gloves.
  • ASTM D 5712 95: Standard Test Method for Analysis of Aqueous Extractable Protein in Latex and Natural Rubber Products Using the Modified Lowry Method.
  • Biocompatibility Standards: Referring to tests for Primary Skin Irritation and Dermal Sensitization (typically conducted following ISO 10993 series or equivalent guidelines).

8. The sample size for the training set:

• Not Applicable. This is a physical device, not a machine learning model, so there is no 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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The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) 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.

The Powder Free Latex Examination Glove, Sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01ε1 and FDA 21 CFR 800.20.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Device: Powder Free Latex Examination Glove, Sterile (Protein Content Labeling)

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 "Device Performance" for various characteristics, implying testing was conducted, but the specific number of gloves or samples tested for each characteristic is not provided.
• Data provenance: Not explicitly stated, but the submission is from a Malaysian company (WRP Specialty Products Sdn. Bhd.). The testing appears to be internal to the manufacturer or conducted by a third-party lab on behalf of the manufacturer, to demonstrate compliance with international standards (ASTM and FDA regulations). The data would be considered retrospective in a regulatory submission context, as it's presented after the tests were performed.

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. The device is a medical glove, and its performance is assessed against recognized engineering and safety standards (ASTM standards and FDA regulations) through physical and chemical testing, rather than through expert interpretation of a specific condition or imaging.
• The "ground truth" for these tests would be the measured results from the laboratory testing, compared against the specified limits in the standards.

4. Adjudication method for the test set:

• This is not applicable as the "test set" involves physical and chemical property measurements against pre-defined standards, not subjective assessments 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:

• No MRMC study was done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI), not for basic medical devices like examination gloves.

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

• No standalone algorithm performance study was done. This concept is not applicable to a medical examination glove.

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

• The ground truth for the device performance claims is established by objective measurements and laboratory testing against specified physical, chemical, and biological criteria defined in recognized standards (ASTM D 3578-01ε1, ASTM D 6124-00, ASTM D 5712-99) and FDA regulations (21 CFR 800.20).
• For biocompatibility, the ground truth is established by standard biological evaluation tests (Primary Skin Irritation in Rabbits, Dermal Sensitization), which result in a "Pass" or "Fail" based on observed reactions.

8. The sample size for the training set:

• This is not applicable. Medical gloves do not typically involve a "training set" in the context of machine learning or AI models. The testing is for product quality and safety validation, not for training an algorithm.

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

• This is not applicable, as there is no "training set." The performance is validated against established industry and regulatory standards.

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The 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.
The patient examination glove may also provides additional protection in other areas where users are handling certain hazardous chemical such as commonly used chemotherapy drugs, as penetration and permeation by these drugs are resisted.

The Powder Free Latex Examination Gloves, Non Sterile with Protein Content Labeling Claim (50 Microgram or less) and Tested for Use with Chemotherapy Drugs meets all the requirements of ASTM standard D 3578 - 0151 and FDA 21 CFR 800.20.

Here's a breakdown of the acceptance criteria and study information for the "Dermagrip Powder Free Latex Examination Gloves" based on the provided 510(k) summary:

This device is a medical glove, and the studies performed are for validating performance characteristics against established ASTM (American Society for Testing and Materials) and FDA standards, not for evaluating an AI algorithm's diagnostic performance. Therefore, many of the requested categories related to AI studies (e.g., sample size for training, ground truth for training, MRMC studies, standalone algorithm performance, number of experts for ground truth, adjudication methods) are not applicable to this type of device and study.

Acceptance Criteria and Reported Device Performance

Study Information (Non-AI Device)

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

   • The document does not explicitly state specific sample sizes for each test in terms of number of gloves or specific batches. However, compliance with ASTM and FDA standards implies that appropriate sample sizes would have been used as specified by those standards for each particular test (e.g., AQL for pinholes, multiple specimens for physical properties).
   • Data Provenance: Not explicitly stated, but the submission is from a Malaysian company (WRP Specialty Products Sdn Bhd), so the testing would likely have been conducted in line with international standards recognized by that region and the U.S. FDA. The testing is performed on the device itself rather than patient data, so "country of origin of the data" in a patient context is not applicable. The studies are prospective in the sense that they are performed on manufactured product to demonstrate compliance.

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

   • Not applicable. This is for a non-AI medical device (gloves). Ground truth is established by objective physical, chemical, and biological tests governed by the specified ASTM and FDA standards, not by expert consensus on interpretations of data.

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

   • Not applicable. This is for a non-AI medical device. The results are determined by adherence to standardized test methods and criteria, not by human adjudication of interpretations.

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:

   • Not applicable. This is for a non-AI medical device. No MRMC study was performed as no "readers" or "AI assistance" are involved.

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

   • Not applicable. This is for a non-AI medical device. No algorithm is involved.

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

   • The "ground truth" for this device's performance is objective measurement against specified performance criteria defined by internationally recognized standards (ASTM) and regulatory requirements (FDA). This includes:
     • Physical measurements: (e.g., dimensions, force at break for physical properties).
     • Chemical analysis: (e.g., protein content, residual powder count).
     • Biological testing: (e.g., primary skin irritation, dermal sensitization in animal models).
     • Permeation testing: (e.g., breakthrough time for chemotherapy drugs).

7. The sample size for the training set:

   • Not applicable. As a non-AI device, there is no "training set" in the machine learning sense. The tests are performed on representative samples of the manufactured gloves.

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

   • Not applicable, as there is no training set for an AI algorithm.

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A 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.

The Powder Free Purple Nitrile Examination Gloves, Non Sterile meets all the requirements of ASTM standard D 6319 -- 00af1 and FDA 21 CFR 800.20.

1. Acceptance Criteria and Device Performance:

2. Sample Size and Data Provenance (Test Set):

The document does not explicitly state a specific sample size used for the test set. Instead, it refers to the device meeting the requirements of ASTM D 6319 – 00aEI, ASTM D 6319 – 00dEI, FDA 21 CFR 800.20, and ASTM D 6124 – 01. These standards inherently specify their own sampling plans and methods for evaluating product characteristics.

The data provenance is implied to be from testing conducted by the manufacturer, WRP Specialty Products Sdn Bhd, in MALAYSIA, as part of their submission to the FDA. The data is retrospective in the sense that it represents results from prior testing to demonstrate compliance with established standards.

3. Number and Qualifications of Experts for Ground Truth (Test Set):

The study relies on established industry and regulatory standards (ASTM and FDA regulations) for acceptance criteria rather than individual expert establishment of ground truth for each test case. Therefore, there is no mention of a specific number of experts or their qualifications for establishing the ground truth for an independent test set in the traditional sense of a clinical study. The "ground truth" is defined by the parameters and thresholds set forth in the referenced standards.

4. Adjudication Method (Test Set):

There is no adjudication method described in the document as it pertains to an independent test set. The evaluation is based on meeting predefined performance criteria outlined in industry standards and FDA regulations, which typically involve laboratory testing and quantitative measurements against these criteria.

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

No MRMC comparative effectiveness study was done. The device is a patient examination glove, and the evaluation is based on material and performance characteristics against established standards, not on human interpretation or diagnostic accuracy where an MRMC study would be relevant.

6. Standalone Performance:

Yes, a standalone performance evaluation was done. The "Device Performance" column in the table directly reports the device's ability to meet the specified standards independently. The evaluation of glove characteristics like dimensions, physical properties, freedom from pinholes, powder-free status, and biocompatibility are intrinsic to the device itself and do not involve human-in-the-loop performance for their assessment.

7. Type of Ground Truth Used:

The ground truth used is based on established industry standards and regulatory requirements. Specifically, ASTM standards (D 6319 – 00aEI, D 6319 – 00dEI, D 6124 – 01) and FDA regulations (21 CFR 800.20) define the acceptable limits and performance characteristics for patient examination gloves. Biocompatibility testing results (Primary Skin Irritation in Rabbits, Dermal Sensitization) also serve as a form of ground truth based on established biological testing protocols.

8. Sample Size for the Training Set:

The document does not describe a "training set" in the context of machine learning or AI. This submission is for a medical device (patient examination gloves) where compliance is demonstrated through laboratory and material testing against established standards, not through iterative model training.

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

As there is no training set in the context of AI/machine learning, the concept of establishing ground truth for a training set is not applicable to this device submission. The underlying principles for manufacturing and quality control of such gloves are guided by the same industry and regulatory standards that define the acceptance criteria for the final product.

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The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) is a disposable device intended for medical purposes that is worn by surgeon's and / or operating room personnel to protect a surgical wound from contamination.

The Powder Free Polymer Coated Latex Surgical Glove, Sterile with Protein Content Labeling (50 micrograms or less) meets all the requirements of ASTM Standard D 3577 - 00 and FDA 21 CFR 800.20.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study:

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 sample size for the test set used for each characteristic. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing was conducted by the manufacturer, WRP Specialty Products Sdn. Bhd. in MALAYSIA.

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

This type of study (evaluating physical and chemical properties of surgical gloves) does not typically involve human experts establishing a "ground truth" for the test set in the same way clinical diagnostic devices do. The ground truth for these characteristics is established by objective, standardized laboratory measurements against defined ASTM and FDA standards.

4. Adjudication Method

Not applicable. The evaluation relies on objective laboratory tests against pre-defined standards, not human interpretation that would require adjudication.

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

No. A MRMC comparative effectiveness study is not applicable to the evaluation of surgical glove physical and chemical properties. This type of study is used for diagnostic devices where human readers interpret medical images or data.

6. Standalone Performance Study

Yes, in a sense. The reported "Device Performance" for each characteristic (dimensions, physical properties, freedom from pinholes, powder-free, protein level, and biocompatibility through skin irritation and dermal sensitization tests) represents the standalone performance of the device as measured against established objective standards. It's an algorithm (or device) only evaluation, as there is no human-in-the-loop performance involved in these specific tests.

7. Type of Ground Truth Used

The ground truth used is based on:

• Objective, standardized laboratory measurements: For dimensions, physical properties, freedom from pinholes, powder-free content, and protein level. These are quantitative or qualitative assessments against specific ASTM (American Society for Testing and Materials) standards and FDA regulations.
• Biological assay results: For biocompatibility (Primary Skin Irritation in Rabbits and Dermal Sensitization), the ground truth is established by the outcome of standard biological tests indicating whether the material is an irritant or sensitizer.

8. Sample Size for the Training Set

Not applicable. This device is a physical product (surgical glove) and not an AI/ML algorithm that requires a training set. The "design" and "manufacturing process" for such a device are validated through established engineering principles and quality control, rather than through a machine learning training paradigm.

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

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

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A 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.

The Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling) meets all the requirements of ASTM standard D 3578 - 01 Type I and FDA 21 CFR 800.20.

The device in question is the "Powder Free Blue Latex Examination Glove, Non-sterile (Protein Content Labeling)", which is a patient examination glove.

Acceptance Criteria and Device Performance:

The acceptance criteria for the glove are based on established ASTM standards and FDA regulations. The device's performance is reported to meet all these criteria.

Study Information:

For this type of medical device (patient examination glove), the submission explicitly states that clinical data is not needed. The assessment of device performance relies on non-clinical performance data, which includes the physical and chemical tests outlined in the table above.

Given that no clinical study was conducted or required:

1. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used. The performance is based on laboratory testing against standards for characteristics like dimensions, physical properties, pinholes, powder content, and protein level. These tests are typically performed on samples from manufacturing batches. The data provenance would be from manufacturing and testing facilities in Malaysia (country of origin for the submitter).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical and chemical tests is established by adhering to widely accepted ASTM standards and laboratory protocols, not by expert consensus in a clinical setting.
3. Adjudication method for the test set: Not applicable, as there was no clinical test set requiring adjudication. Laboratory test results are compared directly against the specified standards.
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: Not applicable. This device is a physical medical glove, not an AI-powered diagnostic or assistive tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
6. The type of ground truth used: For the physical and chemical properties, the "ground truth" is defined by the objective measurements and parameters set forth in the ASTM standards (e.g., specific tensile strength values, elongation percentages, maximum allowable pinholes per unit, maximum powder/protein content). For biocompatibility, the ground truth is established by the observed biological response in animal models (absence of primary skin irritation or contact sensitization).
7. The sample size for the training set: Not applicable, as no algorithm or AI model was involved that would require a training set.
8. How the ground truth for the training set was established: Not applicable.

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The Powder Free Latex Examination Gloves with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile 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.

The Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile meets all the requirements of ASTM Standard D 3578 - 00 and FDA 21 CFR 800.20.

The medical device in question is the "Powder Free Latex Examination Glove with Aloe Vera and Protein Content Labeling Claim (50 micrograms or less), Non Sterile." The study described is a non-clinical performance evaluation comparing the device's characteristics against established standards.

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 specific test (e.g., number of gloves tested for dimensions, pinholes, etc.). It only references that the tests were performed according to the specified ASTM standards, which would typically define the sampling plans.

The data provenance is from non-clinical performance tests conducted in relation to Malaysian manufacturing by WRP Specialty Products Sdn. Bhd. It is neither prospective nor retrospective clinical data, but rather laboratory testing of the product.

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 to this type of device and study. The "ground truth" for the performance characteristics of examination gloves is established by the ASTM and FDA standards themselves, which define measurable, objective criteria (e.g., specific dimensions, tensile strength, protein limits). There are no human experts "establishing ground truth" for each individual test conducted on these gloves in the way that, for example, a radiologist would establish ground truth for an image-based AI device. The tests are based on standardized methodologies and measurements.

4. Adjudication method for the test set:

This information is not applicable. The tests are objective measurements against defined standards. There is no concept of adjudication or consensus among experts for the results of tests like glove dimensions or protein content.

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 not an AI or imaging device; it is a medical device (examination gloves). Therefore, no MRMC study, human readers, or AI assistance is relevant to its evaluation.

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

This is not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used:

The "ground truth" used is defined by verifiable, objective standards and test methodologies. For example:

• Dimensions, Physical Properties, Freedom from Pinholes: Defined by ASTM D 3578 - 00 and FDA 21 CFR 800.20, which specify acceptable ranges for measurements and defect rates.
• Powder-Free: Defined by ASTM D 6124 - 00, specifying a maximum allowable powder residue.
• Protein Level: Defined by ASTM D 5712 - 99, specifying a maximum allowable protein level.
• Biocompatibility: Determined by standardized in vivo tests (Primary Skin Irritation in Rabbits, Dermal Sensitization) that yield objective "Pass/Fail" results based on predefined criteria.

8. The sample size for the training set:

This information is not applicable. This device is not an AI model requiring a training set. The performance evaluation is based on testing a sample of manufactured gloves against established standards.

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

This is not applicable. There is no training set for this device.

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Ask a specific question about this device