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Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device also complies with requirements for standard practice for assessment of resistance of medical gloves to permeation by chemotherapy drugs as per ASTM D6978- 05(2019)

The provided document is a 510(k) Premarket Notification for "Blue Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs." This document clears a medical device (examination gloves) for market and is not an AI/ML device study. Therefore, most of the requested information about acceptance criteria and study design for AI/ML performance is not applicable within this context.

However, I can extract information related to the performance of these physical medical gloves as detailed in the provided document, specifically related to their physical properties and chemical resistance.

Here's the relevant information based on the document:

Study Purpose: To demonstrate that the "Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy Drugs" are as safe, effective, and perform as well as the legally marketed predicate device (Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) K210944).

Lack of AI/ML Study: This document does not describe a study involving an AI/ML device. It pertains to a physical medical device (examination gloves). Therefore, specific criteria and study details related to AI/ML device performance (such as sample size for test/training sets for AI, data provenance for AI, number of experts for AI ground truth, human reader improvement with AI assistance, standalone AI performance) are not present in this document and cannot be provided.

Acceptance Criteria and Device Performance (for Physical Device - Gloves):

The performance of the gloves was evaluated against ASTM standards for various physical properties and for resistance to chemotherapy drugs. The acceptance criteria and reported device performance are presented in the tables below.

Table 1: Physical Properties Acceptance Criteria and Device Performance

Table 2: Biocompatibility Testing Acceptance Criteria and Device Performance

Table 3: Chemotherapy Drug Permeation Acceptance Criteria and Device Performance

(Note: The "acceptance criteria" here is implied by the predicate device's performance for comparison, and the requirement to report the minimum breakthrough detection time. A longer time generally indicates better performance.)

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

• The document primarily refers to testing done in accordance with ASTM standards. These standards specify sample sizes for testing (e.g., for AQL testing for pinholes, or for physical properties). The exact number of samples for each specific test (e.g., how many gloves for tensile strength or how many for chemical permeation) is not explicitly stated in the summary, but it would be prescribed by the referenced ASTM standards (e.g., ASTM D6319-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D6978-05).
• Data Provenance: The applicant for the device is Aspen Glove Sdn. Bhd., located in Malaysia. The testing would presumably have been conducted there or by a certified lab, but specific country of origin for the data (i.e., where the tests were physically performed) is not explicitly stated beyond the applicant's location. The testing would be prospective in nature as it evaluates the manufactured product.

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

• This is not applicable as this is a physical medical device and not an AI/ML device requiring establishment of "ground truth" by clinical experts for image interpretation or similar tasks. The "ground truth" for the physical properties and chemical resistance is established by validated laboratory testing methods conforming to recognized international standards (ASTM, ISO).

4. Adjudication Method for the Test Set:

• Not applicable. This is not a study requiring adjudication of expert interpretations but rather laboratory testing against established physical and chemical standards.

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

• Not applicable. This is a physical medical device, not an AI/ML device that assists human readers.

6. Standalone (Algorithm Only) Performance:

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

7. Type of Ground Truth Used:

• For physical and biocompatibility properties: Ground truth is established by validated laboratory testing methods against recognized industry standards (ASTM, ISO) with numerical or pass/fail criteria.
• For chemotherapy drug permeation: Ground truth is established by laboratory testing per ASTM D6978-05 (2019), measuring the minimum breakthrough detection time.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device requiring a 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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Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free.

The document provided is a 510(k) premarket notification for "Latex Examination Powder Free Gloves." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data against established standards for medical gloves, rather than clinical studies using AI.

Therefore, the requested information regarding AI study details (sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI, how ground truth for training was established) is not applicable to this submission, as it does not involve an AI/ML powered device.

However, I can extract the acceptance criteria and device performance based on the non-clinical tests described.

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 describes a series of non-clinical, controlled laboratory tests performed according to ASTM and ISO standards for medical gloves. Specific sample sizes for each test are not explicitly stated in the provided summary, beyond the "AQL 1.5" for water tightness (which relates to the acceptable quality level for sampling, not the total sample size tested).
• Data provenance: The tests were conducted to specific international and US standards (ASTM, ISO, USP). The manufacturing entity, Aspen Glove Sdn. Bhd., is based in Malaysia, suggesting the tests were likely performed in or commissioned by the manufacturer within that region, or by certified testing labs. The data is prospective for the purpose of demonstrating the device meets the 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)

• Not Applicable. This is a non-AI device. Ground truth in this context refers to the defined scientific and engineering standards (e.g., ASTM, ISO) and the results of laboratory measurements against those standards. The "experts" are the qualified laboratory personnel conducting the tests and interpreting the results according to the test methodologies. The document does not specify the number or qualifications of these testing personnel.

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

• Not Applicable. This is a non-AI device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies with human readers to establish consensus ground truth for complex interpretations (e.g., medical image diagnosis). For physical and chemical tests, the results are objectively measured against established 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 is a non-AI device. MRMC studies are used to evaluate diagnostic performance of AI-assisted systems.

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

• Not Applicable. This is a non-AI device. "Standalone" performance testing refers to the evaluation of an AI algorithm without human involvement.

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

• For this device, the "ground truth" is defined by the established performance specifications and methodologies outlined in the referenced standards (ASTM, ISO, USP). The device's characteristics (length, width, tensile strength, elongation, thickness, powder residue, extractable protein, biocompatibility, water tightness, bacterial endotoxin) are quantitatively measured and compared against the predefined numerical or qualitative acceptance criteria from these standards.

8. The sample size for the training set

• Not Applicable. This is a non-AI device and does not involve machine learning training sets.

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

• Not Applicable. This is a non-AI device and does not have a "training set" or corresponding ground truth establishment process in the context of AI.

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A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Sterile Latex Surgical Gloves Powder Free is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D3577 -09(2015), Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No color is added). The proposed device is sterilized using Gamma method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.

The provided document is a 510(k) Premarket Notification for a medical device: "Sterile Latex Surgical Gloves powder free." This document focuses on demonstrating substantial equivalence to an existing predicate device, rather than proving the device meets clinical acceptance criteria for an AI/ML medical device. Therefore, many of the requested points related to AI/ML study design (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable to this type of submission.

However, the document does contain information about performance testing against established standards, which serve as the acceptance criteria for this specific device.

Here's an analysis of the provided information, addressing the relevant points and noting those that are not applicable:

Device Name: Sterile Latex Surgical Gloves powder free
Submission Type: 510(k) Premarket Notification (for substantial equivalence)

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

The document provides extensive tables comparing the subject device's performance to the predicate device and against the specifications outlined in relevant ASTM standards. These standards define the "acceptance criteria" for the physical and chemical properties of surgical gloves.

Summary Table of Acceptance Criteria and Reported Performance (Selected Key Parameters)

Note on Biocompatibility (Cytotoxicity): The device reported "Cytotoxic" against an acceptance criteria of "non-cytotoxic." However, the comparison table in Section G.c notes that the predicate device (K192328) also tested "Cytotoxic" for this parameter. This indicates that while the specific test result might seem like a failure in isolation, in the context of demonstrating substantial equivalence to a legally marketed predicate, it is acceptable if the predicate device exhibits the same characteristic and is already on the market. The FDA would have cleared the predicate with this characteristic, implying it's acceptable for surgical gloves.

Study that proves the device meets the acceptance criteria:

The document describes non-clinical bench testing conducted to verify that the proposed device meets design specifications and acceptance criteria outlined in various industry standards (primarily ASTM and ISO).

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

• Sample Size: The document does not explicitly state the sample size for each test performed. However, the tests are performed according to recognized international standards (ASTM, ISO, USP), which typically specify minimum sample sizes for reliable results. For example, ASTM D5151-06 (Detection of Holes in Medical Gloves) employs an Acceptable Quality Level (AQL) methodology, implying a statistically determined sample size tested for pinholes.
• Data Provenance: The tests were conducted to support a 510(k) submission for a manufacturer in Malaysia (Aspen Glove Sdn. Bhd.). The data itself is "bench test" data. It is not patient data, so "retrospective or prospective" does not apply in the typical sense of a clinical study.

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)

• Not Applicable. This is not a study involving expert readers or establishment of ground truth by human experts, as it is a physical device (surgical glove) and not an AI/ML diagnostic tool. The "ground truth" here is defined by the technical specifications and test methods within the referenced ASTM and ISO standards.

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

• Not Applicable. This is a physical device performance study, not an imaging or diagnostic study requiring adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This 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 (expert consensus, pathology, outcomes data, etc)

• The "ground truth" in this context is the established technical and performance specifications defined by international consensus standards (ASTM D3577-09, ASTM D5151-06, ASTM D6124-06, ISO 10993 series, USP). These standards outline the physical and chemical properties and safety requirements for such medical devices, and the tests verify compliance with these objective measures.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device and thus does not have a "training set."

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

• Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is irrelevant.

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Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

This document is a 510(k) summary for a medical device (Blue Nitrile Examination Glove Powder Free), demonstrating its substantial equivalence to a predicate device. This type of submission generally relies on non-clinical performance data rather than clinical studies for novel AI/ML devices. Therefore, a direct application of the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" for AI/ML performance (e.g., accuracy, sensitivity, specificity, MRMC studies) is not present here.

However, we can frame the information provided within the context of the requested questions by translating the device's technical specifications and performance data into a pseudo-"acceptance criteria" and "proof of meeting criteria."

Here's a breakdown based on the provided document:

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

For a physical device like a medical glove, "acceptance criteria" relate to its physical and biocompatibility properties, and "performance" refers to the test results demonstrating compliance with these standards.

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

• Sample Size: The document does not explicitly state the specific numerical sample size for each test. Instead, it references conformity to ASTM and ISO standards, which typically prescribe statistical sampling plans. For instance, AQL (Acceptable Quality Level) 1.5 for water tightness implies a specific sampling size based on lot size, but the exact count isn't given.
• Data Provenance: The device is manufactured by Aspen Glove Sdn. Bhd. in Malaysia. The testing was presumably conducted by the manufacturer or a certified lab. The provenance of the "data" itself is from laboratory tests performed on the physical glove product. The data is retrospective in the sense that the testing was completed before the 510(k) submission.

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

• This question is not applicable in the context of this device. "Ground truth" from expert readers (like radiologists) is relevant for AI-powered diagnostic devices interpreting medical images. For a physical device like a glove, the "ground truth" is established by adherence to globally recognized consensus standards (ASTM, ISO, USP) and the results of laboratory tests performed according to validated methods. The "experts" involved are the scientists and technicians who perform these standardized tests and the regulatory bodies who define the standards.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used to establish ground truth in studies where human interpretation is subjective or requires consensus (e.g., AI in radiology). For a physical product's performance characteristics, the "adjudication" is inherently built into the standardized test methods, where results are measured objectively against defined 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. MRMC studies are designed for evaluating AI in diagnostic imaging by comparing human performance with and without AI assistance. This document describes a medical glove, not an AI diagnostic tool.

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

• Not applicable. This question pertains to the performance of an AI algorithm in isolation. The document describes a physical medical device.

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

• The "ground truth" for this device is based on established consensus standards and objective laboratory measurements (e.g., dimensions, tensile strength measured by equipment, chemical analysis for powder residue, standardized biological assays for biocompatibility). There is no "expert consensus" in the sense of physicians or pathologists interpreting findings, but rather adherence to scientifically defined parameters and test methodologies.

8. The sample size for the training set

• Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

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

• Not applicable. Similar to point 8, there is no training set or corresponding ground truth establishment process for a physical device.

In summary: This FDA 510(k) submission for a medical glove demonstrates substantial equivalence primarily through non-clinical testing against established physical and biocompatibility standards. The framework requested (acceptance criteria, study design, expert involvement, etc.) is most appropriate for AI/ML-driven diagnostic or therapeutic devices, rather than traditional Class I or II physical medical devices where performance is assessed through standardized laboratory tests.

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