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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 acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.

The provided text is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". It details the device's characteristics, intended use, and a comparison to a predicate device. The document explicitly states that clinical testing is not applicable and that clinical data is not needed for gloves or for most devices cleared by the 510(K) process.

Therefore, there is no information in the provided text regarding a study that proves the device meets acceptance criteria related to AI or human-in-the-loop performance, as this is a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool.

However, I can extract the acceptance criteria and reported performance for the non-clinical tests conducted on the device, which are relevant for demonstrating its substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Regarding the other requested information (2-9), as a physical medical device (gloves) and not an AI/software device, these questions are not applicable to the context of the provided document.

• 2. Sample size used for the test set and the data provenance: Not applicable. (These are physical tests on glove samples, not a test set for AI performance).
• 3. Number of experts and qualifications: Not applicable. (These are standardized physical and biological tests).
• 4. Adjudication method: Not applicable. (These are standardized physical and biological tests).
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted image interpretation or similar.
• 6. Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is for AI algorithms.
• 7. Type of ground truth used: Not applicable in the AI sense. The "ground truth" for these tests comes from established industry standards (ASTM, ISO, USP) for physical and chemical properties and biological responses.
• 8. Sample size for the training set: Not applicable. Applies to AI/machine learning.
• 9. How the ground truth for the training set was established: Not applicable. Applies to AI/machine learning.

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Amazing+ 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.

Amazing Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, 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 provided text is a 510(k) Summary for a medical device: "Amazing+ Latex Examination Powder Free Gloves." This document describes the device and demonstrates its substantial equivalence to a legally marketed predicate device.

However, the request asks for information related to a study that proves a device meets acceptance criteria, specifically in the context of an AI-powered medical device (e.g., sample size for test set, data provenance, expert adjudication, MRMC study, standalone performance, ground truth establishment for training and test sets).

The provided 510(k) Summary does not describe an AI medical device. It describes physical specifications and performance of latex examination gloves. Therefore, many of the requested fields are not applicable to this type of device.

Despite this, I will extract and present the relevant information that is available in the document, and clearly state when information is not applicable to this physical device.

Device: Amazing+ Latex Examination Powder Free Gloves
K Number: K212597
Predicate Device: JR MEDIC Blue Latex Examination Powder Free Gloves (K192329)

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

Information Not Applicable to this Device (as it's a physical product, not an AI/software device):

Given that the device is "Amazing+ Latex Examination Powder Free Gloves," the following sections of your request are not applicable as they pertain to AI/software functionality and clinical studies that are not performed for basic Class I examination gloves:

• 2. Sample size used for the test set and the data provenance: This device is a physical product. Testing involves laboratory measurements on physical samples (e.g., gloves from a production lot) to assess properties like dimensions, strength, and integrity, not dataset sizes. The provenance is from "Amazing Rubber Products Pvt. Ltd." in Cochin, Kerala, India. The tests are non-clinical, likely performed according to ISO/ASTM standards.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by standardized measurement methods (e.g., ASTM standards), not expert opinion or consensus.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Physical measurements do not require adjudication.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for device performance is based on the specified ASTM and ISO standards for physical and chemical properties and biocompatibility testing.
• 8. The sample size for the training set: Not applicable. There is no "training set" for physical examination gloves; manufacturing process controls ensure consistent product.
• 9. How the ground truth for the training set was established: Not applicable. See above.

Summary of Non-Clinical Performance Data (Reiterated from document):

The performance test data of the non-clinical tests meet the following standards:

• ASTM D 3578-2019 Standard Specification for Rubber Examination Gloves
• ASTM D 5151-2019 Standard Test Method for Detection of Holes in Medical Gloves
• ASTM D 6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
• ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber

Clinical Testing Summary:

• "This section is not applicable because clinical data not needed for gloves." (As stated in the document).

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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 with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein 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 D3577-2019, 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 and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for Sterile Latex Surgical Gloves Powder Free (K212596), intended to be worn in operating rooms. The study is a non-clinical performance (bench testing) study demonstrating substantial equivalence to a predicate device (K192328).

Here's the breakdown of the information requested, based on the provided document:

Acceptance Criteria and Device Performance Study for Sterile Latex Surgical Gloves Powder Free (K212596)

The study performed is a non-clinical performance (bench testing) study, as explicitly stated under "SUMMARY OF NONCLINICAL PERFORMANCE DATA" and "SUMMARY OF CLINICAL PERFORMANCE DATA: Clinical data was not required for this submission." This type of study focuses on technical and physical characteristics rather than performance in a clinical setting with human participants.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally based on ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves, and other specific standards for each test.

Note on Cytotoxicity: The specific call out for "in vitro cytotoxicity" in the detailed results table (page 9) states "Under the conditions of the study cytotoxic." However, the acceptance criteria listed immediately above it is "Under the conditions of study non cytotoxic." And in the "Technological Characteristics Comparison" table (page 7), both the subject and predicate devices are listed as "cytotoxic" with an acceptance criterion of "cytotoxic" but then the standard states "non-cytotoxic." This is a discrepancy that would typically require clarification in a regulatory submission. Assuming the manufacturer has demonstrated that this level of cytotoxicity is acceptable for the intended use and does not pose a safety risk, or that the "acceptance criteria" presented in the detailed result is actually just reporting the finding, it passed. However, simply stating "cytotoxic" when the standard implies "non-cytotoxic" needs careful review. For the purpose of this summary, it's listed as reported.

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

• Sample Size: The document does not explicitly state the exact sample sizes (number of gloves) used for each bench test. Standards like ASTM D3577 typically specify sampling plans (e.g., AQL levels for defect testing).
• Data Provenance: The tests were conducted internally by the manufacturer or by contracted labs. The manufacturer is Amazing Rubber Products Pvt. Ltd. located in Kerala, India. The data is retrospective in the sense that it was collected as part of the device development and verification process to support 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 information is not applicable as the study is a bench test verification of physical and chemical properties against established industry standards (e.g., ASTM, ISO, USP). Ground truth in this context is defined by these measurable standards and the associated testing methodologies, not by expert interpretation of, for example, medical images.

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

• This information is not applicable as the study is a bench test verification. Adjudication methods are typically used in clinical studies, especially those involving human interpretation (e.g., radiology reads) to resolve discrepancies.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices where human performance is being evaluated or improved with AI assistance. The device in question is a surgical glove, which is a physical product, not a diagnostic tool requiring human reader interpretation.

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

• No, this is not applicable. The device is a physical product (surgical glove), not an algorithm or AI system. Its performance is assessed through bench testing against established performance standards.

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

• The "ground truth" for this device is defined by established international and national standards and specifications for surgical gloves (e.g., ASTM D3577-2019, ISO 10993 series, USP monographs). These standards specify the acceptable physical, chemical, and biological properties through defined test methods.

8. The sample size for the training set

• Not applicable. This question pertains to machine learning models. The device is a physical product, not an AI/ML model that requires training.

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

• Not applicable. As above, this pertains to machine learning models.

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

Sterile Nitrile Patient Examination Gloves Powder Free Blue Color 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. Both Gamma & ETO sterilized gloves are available in X-Small, Small, Medium, Large & X-Large sizes.

The provided document is a 510(k) summary for a medical device: "Sterile Nitrile Patient Examination Gloves Powder Free Blue Color". This summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets acceptance criteria through a specific study with AI or human readers. Therefore, many of the requested items (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as it does not describe an AI/software study.

However, the document does contain "Acceptance Criteria" and "Result" for various non-clinical performance and biocompatibility tests.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This document describes physical and biocompatibility testing, not an AI/software study with a test set of data. The "test sets" here would refer to the number of gloves tested per batch or samples for biocompatibility - which is not specified in detail.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is established through standardized laboratory testing methods (e.g., ASTM D6319, ISO 10993 series) and their respective criteria. For instance, for physical properties, it's objective measurements based on the standard. For biocompatibility, it's the observed biological response in animal models or in vitro assays compared to established acceptable limits.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Summary of the study that proves the device meets the acceptance criteria:

The device "Sterile Nitrile Patient Examination Gloves Powder Free Blue Color" underwent a series of non-clinical performance and biocompatibility tests according to recognized international and national standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5, ISO 10993-11, USP 41<151>, USP 42<85>). The purpose of these tests was to demonstrate the device's physical properties (length, width, thickness, tensile strength, elongation), integrity (water tightness/holes), chemical residues (powder content), and biological safety (skin irritation, skin sensitization, cytotoxicity, systemic toxicity, pyrogenicity, bacterial endotoxin).

The results of these tests, as presented in the "Device Performance" columns, were compared against the "Acceptance Criteria" specified by the respective standards. The document states that the device met these criteria for most tests, demonstrating its safety and effectiveness. Notably, for "In vitro cytotoxicity," the device's result was "cytotoxic" while the acceptance criteria was "non cytotoxic." Despite this, the overall conclusion states that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device K171093." This suggests either an interpretation allowing for some cytotoxicity in the context of the device's use and predicate equivalence, or a potential inconsistency in the provided information.

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