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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Powder Free Nitrile Patient Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs meet all of the requirements of ASTM D6319-10. The gloves are ambidextrous single-use disposable devices that come in five sizes (XS, S, M, L, XL) in blue or orange color.

The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. This type of device is a physical product and does not involve AI/ML. Therefore, many of the requested categories in the prompt are not applicable.

Here's the information that can be extracted relevant to the performance of these gloves:

1. Table of Acceptance Criteria and Reported Device Performance

• Palm Thickness ≥ 0.10mm
• Finger Thickness ≥ 0.10mm
• Widths: X-Small 70-80mm, Small 80-90mm, Medium 90-100mm, Large 101-111mm, X-Large ≥ 111mm | Meets Standard Requirements |
  | Physical Properties | ASTM D6319-10 (Before Aging: Tensile Strength ≥ 14 MPA, Elongation > 500%; After Aging: Tensile Strength ≥ 14 MPA, Elongation > 400%) | - Before Aging: Tensile Strength ≥ 14 MPA, Elongation > 500%
• After Aging: Tensile Strength ≥ 14 MPA, Elongation > 400% | Meets Standard Requirements |
  | Freedom from Pinholes | ASTM D5151-11, ASTM D6319-10 (Pass quality level at G1 AQL 1.5) | Tested in accordance with ASTM D5151 test method. Pass quality level at G1 AQL 1.5 | Meets Standard Requirements |
  | Powder Free Residue | ASTM D6124-11, ASTM D6319-10 (≤ 2 mg of residual powder per glove) | Result generated values ≤ 2 mg of residual powder per glove | Meets Standard Requirements |
  | Biocompatibility (Dermal Sensitization) | ISO 10993-10:2010 (Not a contact skin sensitizer) | Not a contact skin sensitizer | Meets Standard Requirements |
  | Biocompatibility (Primary Skin Irritation Test) | ISO 10993-10:2010 (Not a primary skin irritant) | Not a primary skin irritant | Meets Standard Requirements |
  | Chemotherapy Drug Permeation (Blue Glove) | ASTM D6978-05 (Minimum Breakthrough Detection Time in Minutes) | Carmustine (3.3 mg/ml): 15.1
  Cisplatin (1.0 mg/ml): >240
  Cyclophosphamide (20 mg/ml): >240
  Cytarabine (100 mg/ml): >240
  Dacarbazine (DTIC) (10.0 mg/ml): >240
  Doxorubicin Hydrochloride (2.0 mg/ml): >240
  Etoposide (20.0 mg/ml): >240
  Fluorouracil (50.0 mg/ml): >240
  Ifosfamide (50.0 mg/ml): >240
  Methotrexate (25 mg/ml): >240
  Mitomycin C (0.5 mg/ml): >240
  Mitoxantrone (2.0 mg/ml): >240
  Paclitaxel (Taxol) (6.0 mg/ml): >240
  Thiotepa (10.0 mg/ml): >240
  Vincristine Sulfate (1.0 mg/ml): >240 | Tested for Use with Chemotherapy Drugs. Carmustine has extremely short permeation times of 15.1 minutes. |
  | Chemotherapy Drug Permeation (Orange Glove) | ASTM D6978-05 (Minimum Breakthrough Detection Time in Minutes) | Carmustine (3.3 mg/ml): 17.9
  Cisplatin (1.0 mg/ml): >240
  Cyclophosphamide (20 mg/ml): >240
  Cytarabine (100 mg/ml): >240
  Dacarbazine (DTIC) (10.0 mg/ml): >240
  Doxorubicin Hydrochloride (2.0 mg/ml): >240
  Etoposide (20.0 mg/ml): >240
  Fluorouracil (50.0 mg/ml): >240
  Ifosfamide (50.0 mg/ml): >240
  Methotrexate (25 mg/ml): >240
  Mitomycin C (0.5 mg/ml): >240
  Mitoxantrone (2.0 mg/ml): >240
  Paclitaxel (Taxol) (6.0 mg/ml): >240
  Thiotepa (10.0 mg/ml): >240
  Vincristine Sulfate (1.0 mg/ml): >240 | Tested for Use with Chemotherapy Drugs. Carmustine has extremely short permeation times of 17.9 minutes. |

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

• Sample Size: The document does not specify a numerical sample size for the various tests (Dimensions, Physical Properties, Freedom from Pinholes, Powder Free Residue, Biocompatibility, Chemotherapy Drug Permeation). It generally refers to testing "in accordance with" the various ASTM and ISO standards, which inherently include sampling plans. For instance, "Pass quality level at G1 AQL 1.5" for pinholes refers to a specific sampling plan within ASTM D5151.
• Data Provenance: The document implies that testing was conducted by the manufacturer, Top Calibre Sdn. Bhd., located in Malaysia. The testing is retrospective, performed to demonstrate compliance with established standards for premarket notification.

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, and the "ground truth" is established through standardized laboratory testing procedures based on material science and safety standards (ASTM, ISO), rather than expert interpretation of data like images.

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

• Not Applicable. As mentioned above, "adjudication" in the context of expert review of data is not relevant for this type of device testing. Performance is measured against objective, quantifiable criteria defined by the 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 a physical device, not an AI/ML algorithm or a system involving human readers.

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

• Not Applicable. This is a physical device, not an AI/ML algorithm.

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

• The "ground truth" is established by the specified ASTM and ISO standards themselves. These standards define the acceptable physical properties, chemical resistance, and biocompatibility limits for patient examination gloves. Laboratory tests are performed to objectively measure these characteristics against the defined thresholds.

8. The sample size for the training set:

• Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.

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

• Not Applicable. There is no "training set" or AI/ML model for which ground truth would be established. Performance is based on direct physical and chemical testing.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010). The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).

This document describes the acceptance criteria and performance of the "Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim".

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 a distinct "test set" in the context of image or algorithmic data. Instead, it details various laboratory tests performed on the physical glove product. The sample sizes for each specific test (e.g., dimensions, physical properties, pinholes, protein content, biocompatibility, chemotherapy permeation) are not explicitly stated in the provided summary. However, it is implied that testing was conducted in accordance with the relevant ASTM and ISO standards, which typically prescribe minimum sample sizes for statistical validity.

Data Provenance: The data provenance is from laboratory testing performed by Top Calibre Sdn Bhd (Malaysia) or a contracted lab under their supervision, to demonstrate compliance with international standards (ASTM, ISO). This is retrospective data collected as part of the device's development and regulatory submission process.

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

N/A. This device is a physical product (medical glove), and the evaluation is based on laboratory performance against defined physical and chemical standards, not on expert interpretation of observational data or images. Therefore, clinical ground truth established by experts is not applicable.

4. Adjudication Method for the Test Set

N/A. As the evaluation is based on objective laboratory measurements against predefined standards, there is no need for an adjudication method as would be used in a clinical study with subjective interpretations.

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

N/A. This is a physical product (glove) and not an AI or imaging device, so MRMC studies are not relevant.

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

N/A. This is a physical product and does not involve an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by:

• International Standards: Primarily ASTM (American Society for Testing and Materials) standards (D3578-05, D5151-11, D6124-11, D5712-10, D6978-05) and ISO (International Organization for Standardization) standards (10993-10:2010) for physical, chemical, and biocompatibility properties. These standards define the acceptable range or threshold for each characteristic.
• Direct Measurement/Testing: Laboratory measurements and assays were conducted to determine the actual performance values of the gloves (e.g., tensile strength, breakthrough time for chemotherapy drugs). These measurements are then compared directly to the specified acceptance criteria within the standards.

8. Sample Size for the Training Set

N/A. This is a physical product and does not involve AI or machine learning algorithms that would require a training set.

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

N/A. As there is no training set for an algorithm, this question is not applicable.

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

Powder Free Latex Patient Examination Glove, with Protein Content Labeling Claim, Chlorinated (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

The provided text is for a 510(k) Premarket Notification for a medical device, specifically a Powder Free Latex Patient Examination Glove. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data and comparison of technological characteristics, rather than extensive clinical studies as one might find for a novel diagnostic AI device.

Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and submission. The "study" here refers to the testing performed to meet specific ASTM standards and biocompatibility requirements.

Here's a breakdown of the information that is applicable and how it relates to the acceptance criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by existing ASTM standards and biocompatibility testing. The device's performance is reported as meeting these standards.

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

The document specifies that the device "meets all the current specification for ASTM D3578-05 (2010)" and refers to other ASTM and ISO standards for specific characteristics. Clinical data was "not needed for market cleared examination gloves."

• Sample Size for Test Set: The specific sample sizes for each test (e.g., pin-holes, dimensions, physical properties) are not detailed in this 510(k) summary. These would typically be specified within the individual ASTM and ISO standards referenced. For example, ASTM D5151-99 for freedom from pinholes often specifies a sample size based on the acceptable quality level (AQL).
• Data Provenance: The document does not explicitly state the country of origin for the data (e.g., where the tests were physically conducted) nor whether it was retrospective or prospective. Given the nature of performance testing against standards, it would be prospective testing of newly manufactured glove batches. The manufacturer is "Top Calibre Sdn Bhd" in Selangor, Malaysia, so the testing was likely conducted by or for them.

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

Not Applicable: This type of device does not involve a "ground truth" established by experts in a diagnostic or interpretive sense. The ground truth for performance characteristics is defined by the objective measurement criteria within the relevant ASTM and ISO standards (e.g., tensile strength, elongation, water leak rate, protein content measurement). Biocompatibility tests are performed by qualified laboratories and assessed against established toxicology criteria.

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 used for human-reviewed data, often in diagnostic imaging or clinical trials, to resolve discrepancies between readers. For physical and chemical tests of gloves, results are objectively measured against defined thresholds in the standards; there is no subjective interpretation 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 device is a patient examination glove, not an AI-powered diagnostic tool. Therefore, MRMC studies and assessments of AI assistance are irrelevant.

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 (glove), not an algorithm or software. Standalone algorithm performance is not relevant.

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

The "ground truth" for this device's performance is established by objective measurements against predefined criteria and thresholds set forth in the referenced ASTM and ISO standards.

• For Dimensions, Physical Properties, Freedom from pin-holes, Powder Free Residue, Protein Content: The ground truth is the quantitative measurement of these properties (e.g., thickness, tensile strength, percentage of gloves passing water leak test, specific protein content in µg/dm²) compared to the specified limits in standards like ASTM D3578-05 (2010), ASTM D5151-99 (2006), ASTM D6124-06, and ASTM D5712-10.
• For Biocompatibility: The ground truth is determined by the results of standardized biological tests (Dermal Sensitization and Primary Skin Irritation Tests as per ISO 10993-10:2010), which assess the device's potential to cause adverse biological reactions. The "ground truth" in this context is the observation of whether a reaction occurs and its severity, interpreted against established toxicity criteria, leading to a "pass" or "fail" determination (e.g., "Not a contact skin sensitizer," "Not a primary skin irritant").

8. The sample size for the training set

Not Applicable: This device does not use machine learning or AI, 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, this question is not relevant.

Ask a specific question about this device

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

Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

Acceptance Criteria and Device Performance Study for K120693 - Powdered Latex Patient Examination Glove

This document describes the acceptance criteria and the study demonstrating that the "Powdered Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 200 Micrograms per dm² of glove or Less of Water Extractable Protein)" (K120693) meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against established ASTM standards and ISO standards for biocompatibility.

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

The document does not explicitly state the sample sizes used for each specific test or the country of origin for the data. However, the evaluation relies on compliance with established ASTM and ISO standards, which typically involve specific sampling plans and test methods. The studies are non-clinical performance tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of medical device (patient examination gloves), the "ground truth" is established by adherence to recognized national and international consensus standards (ASTM and ISO), not by expert consensus on clinical data or image interpretation. The tests are laboratory-based and objective measurements.

4. Adjudication Method for the Test Set

Not applicable. The performance testing involves objective measurements against established standard specifications, not subjective interpretation requiring adjudication among experts.

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

Not applicable. This device is a patient examination glove, and its performance is assessed through non-clinical laboratory testing against physical, chemical, and biocompatibility standards. MRMC studies are typically relevant for diagnostic imaging or similar devices that involve human interpretation of results.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done in the sense that the device itself, a physical product, was subjected to a series of laboratory tests to evaluate its inherent characteristics against the specified standards. Human interaction is limited to conducting the tests according to the standard protocols and recording the objective results.

7. Type of Ground Truth Used

The ground truth used is based on established national and international consensus standards (ASTM and ISO). These standards define objective pass/fail criteria and test methodologies for dimensions, physical properties, freedom from pinholes, powder amount, protein content, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This device is a physical product, not an algorithm or AI model that requires a training set. The evaluation is based on direct testing of the manufactured product batches against standardized criteria.

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

Not applicable, as there is no "training set" for this device. The ground truth for evaluating the device's performance is established by the specified ASTM and ISO standards themselves, which outline the acceptable ranges and test methods.

Ask a specific question about this device

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

Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010).

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

Device: Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm² of glove or Less of Water Extractable Protein)

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 sample sizes used for the specific tests (e.g., freedom from pin-holes, protein content). It only refers to compliance with the ASTM and ISO standards, which would implicitly define sample sizes for those tests. The data provenance is not specified beyond indicating that Top Calibre Sdn Bhd, a Malaysian company, submitted the information. It is a retrospective compilation of compliance to existing standards rather than a prospective clinical trial.

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

Not applicable. The ground truth for this device is based on adherence to established international and national standards (ASTM, ISO) for medical gloves. This does not involve expert consensus on an "image" or "diagnosis" but rather laboratory and performance testing against objective criteria defined by these standards.

4. Adjudication Method for the Test Set

Not applicable. As the device's performance is measured against objective, published standards, there would be no "adjudication" in the sense of reconciling differing expert opinions. The tests conducted according to the standards would yield measurable results that either meet or do not meet the specified criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical decision support AI, where human performance is evaluated with and without AI assistance. This device is a physical examination glove, and its effectiveness is determined by its physical properties and biocompatibility, not by assisting human readers in interpreting clinical data.

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

Yes, the testing described appears to be standalone in the sense that the device itself (the glove) was subjected to laboratory tests and its performance was measured against predefined standards without direct human-in-the-loop performance evaluation in a clinical setting for primary efficacy. The performance metrics are objective physical and chemical properties.

7. Type of Ground Truth Used

The ground truth used is based on established national and international standards for medical gloves. This includes:

• Physical properties defined by ASTM D 3578-05 (2010)
• Freedom from pin-holes defined by ASTM D 5151-99 (2006)
• Powder-free residue defined by ASTM D 6124-06
• Protein content defined by ASTM D 5712-10
• Biocompatibility (dermal sensitization and primary skin irritation) defined by ISO 10993-10:2010

8. Sample Size for the Training Set

Not applicable. This device is an examination glove, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process of the gloves would be subject to quality control, but this is distinct from an algorithm's training data.

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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