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The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05(2019)

Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided document describes the acceptance criteria and study results for the "Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K240080).

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the gloves are based on various physical characteristics, chemical permeation resistance (as per ASTM D6978-05(2019)), and biocompatibility tests (as per ISO 10993 standards). The reported device performance is compared to these criteria and, in some cases, to a predicate device (K200671).

Physical and Design Characteristics (Meeting ASTM D6319-19):

Chemotherapy Permeation Resistance (ASTM D6978-05(2019)):

Fentanyl Citrate Permeation Resistance (ASTM D6978-05(2019)):

Biocompatibility (ISO 10993 Standards):

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 explicitly state the specific sample sizes used for each test. However, it indicates that tests were conducted according to recognized international standards such as ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6978-05(2019) (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs), and ISO 10993 series for biocompatibility. These standards typically specify the number of samples required for testing.

The data provenance is not explicitly stated as 'country of origin' in that format, but the applicant is "Syntex Healthcare Products Co., Ltd" from "Xinji, Hebei, China," indicating the testing likely occurred under their purview or by contracted labs. The studies appear to be prospective testing conducted specifically for this premarket notification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes performance testing of a physical medical device (gloves) against established engineering and biocompatibility standards. It does not involve interpretation of medical images or patient data by human experts for ground truth establishment.

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

This information is not applicable for the same reason as point 3. Testing involves objective measurements against predefined 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

This information is not applicable as the device is a medical glove, not an AI-powered diagnostic or assistive tool.

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

This information is not applicable as the device is a medical glove, not an algorithm.

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

The "ground truth" for this device's performance is based on established international and national standards for medical gloves:

• ASTM D6319-19: for physical dimensions and integrity (e.g., freedom from holes, tensile strength).
• ASTM D6978-05(2019): for resistance to permeation by chemotherapy drugs and Fentanyl Citrate, where "breakthrough detection time" is the key metric.
• ISO 10993 series (ISO 10993-5, -10, -11, -23): for biocompatibility assessments like cytotoxicity, sensitization, irritation, and systemic toxicity.

8. The sample size for the training set

This information is not applicable as the device is a physical product and does not involve machine learning or AI models with training sets.

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

This information is not applicable as the device is a physical product and does not involve machine learning or AI models.

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

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

Aloe Vera: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, and Vincristine Sulfate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.

Non-Sterile, Powder Free Nitrile Examination Gloves: Tested for use with Carboplatin, Carmustine, Cisplatin (BCNU), Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), Fluorouracil, Ifosfamide, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel (Taxol), ThioTEPA, Vincristine Sulfate, and Fentanyl Citrate. WARNING: NOT TO BE USED WITH CARMUSTINE OR THIOTEPA.

Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs and Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate.

The provided text is related to a 510(k) premarket notification for nitrile examination gloves and does not contain information about the acceptance criteria or a study that typically involves AI/ML device performance. Instead, it details the indications for use and the gloves' resistance to permeation by chemotherapy drugs and fentanyl citrate, in accordance with ASTM D6978.

Therefore, I cannot extract the information required to answer your questions as they pertain to AI/ML device performance studies and acceptance criteria. The document focuses on regulatory clearance for medical gloves based on chemical resistance testing, not on an AI/ML algorithm's performance.

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The provided text is a 510(k) clearance letter from the FDA for "Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors."

This document does not contain any information about an AI/ML medical device, its acceptance criteria, or a study proving its performance. It specifically relates to a Class I medical device (non-powdered patient examination glove) and focuses on regulatory aspects like substantial equivalence, general controls, and compliance.

Therefore, I cannot provide the requested information about acceptance criteria and a study to prove a device meets them, as the provided input does not describe such a device or study.

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A patient examination glove is disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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This document does not contain information about the acceptance criteria or a study proving that a device meets acceptance criteria.

The provided text is an FDA 510(k) clearance letter for a "Latex Examination Powder Free Glove, Aloe Vera" (K193150). It states that the device is substantially equivalent to legally marketed predicate devices.

This type of FDA clearance relies on demonstrating substantial equivalence to a predicate device, rather than performing specific clinical studies to meet pre-defined performance acceptance criteria as would typically be required for a novel device or AI-powered medical device.

Therefore, I cannot provide the requested information, which would typically be found in a performance study report or a different section of a submission for a device that requires such evaluation.

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A patient examination glove is disposable glove intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner

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This document is an FDA 510(k) clearance letter for Nitrile Examination Powder Free Gloves. It does not contain information about an AI/ML medical device, its acceptance criteria, or a study proving that such a device meets acceptance criteria.

The information provided in the prompt, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set," "Number of experts used to establish the ground truth," and "If a multi reader multi case (MRMC) comparative effectiveness study was done," are all relevant to the evaluation of AI/ML-driven medical devices. However, this document is for a physical medical device (gloves) and therefore does not include any of these details.

To answer your request, I would need a document related to an AI/ML medical device, not a physical one.

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Intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.

Exsens Personal Lubricants are non-sterile, water-based personal lubricants that provide personal lubrication during intimate sexual activity. They are made up of Glycerin, Water, Propylene Glycol, Aroma (Flavor), Aloe Barbadensis (aloe vera) leaf juice, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Sodium Saccharin and citric acid. The product is packaged in a 70ml polyethylene white tube with a flip-top cap and protective sleeve. It is for over-the-counter (OTC) use.

The document describes the acceptance criteria and performance data for Exsens Personal Lubricants. This information is presented in the context of a 510(k) premarket notification to the FDA, where the device is compared to a predicate device (K-Y Marilyn Pleasure Gel, K151884) to demonstrate substantial equivalence.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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The Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color Non-Sterile, is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

The gloves are coated with Aloe Vera, ambidextrous with beaded cuff, green colored, single use disposable devices that comes in six sizes (XS, S, M, L, XL and XXL) supplied in non-sterile state. The qloves are powder free and are manufactured using online chlorination process to avoid sticky surface and obtain good donning properties.

The gloves are made of Nitrile Butadiene Rubber, designed and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Its physical and performance characteristics meet all requirements of ASTM D6319-10.

This document is a 510(k) premarket notification for a medical device (Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color). The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study of AI performance. Therefore, I cannot provide details on AI acceptance criteria, sample sizes for AI tests, expert qualifications, or MRMC studies.

However, I can extract the acceptance criteria and device performance for the glove itself, as per the submitted documentation.

1. Table of Acceptance Criteria and Reported Device Performance

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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.

Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E

This document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Polychloroprene Examination Gloves - Pink with Aloe Vera and Vitamin E." It does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter is a regulatory approval for marketing the device based on a determination of substantial equivalence to previously marketed devices. It confirms that the device is a Class I medical device (patient examination glove), lists general controls it must adhere to, and provides contact information for further regulatory inquiries.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs.

SensiCare® Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color is to function in the same manner as various other surgical gloves existing in industry today. The proposed SensiCare surgical glove is a disposable device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs. It has limited contact duration (

This document is a 510(k) premarket notification for a medical device: "SensiCare® Sterile Powder-Free Polymer Coated Polyisoprene Surgical Glove, Coated with Aloe Vera (Tested for Use with Chemotherapy Drugs)-Natural Color".

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states a "WARNING: Do not use with Carmustine and Thiotepa" despite reporting permeation times, indicating these times are likely too short for safe use.

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

The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for holes, powder, or chemotherapy permeation). It references standards like ASTM D3577-09e, ASTM D5151-06, ASTM D6124-06, and ASTM D6978-05, which would define the required sample sizes for such tests.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests are non-clinical (laboratory-based performance testing of the device itself) and would have been conducted by the manufacturer or a contracted testing facility to demonstrate compliance with the referenced standards.

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

Not applicable. The ground truth for these device performance tests is established by objective, standardized measurements and adherence to specified test methods within the ASTM and ISO standards, rather than expert consensus on interpretation. For example, breakthrough detection time for chemotherapy drugs is a direct measurement, and a glove either passes or fails based on the objective criteria of the standard.

4. Adjudication Method for the Test Set

Not applicable. As described above, these are objective performance tests with defined pass/fail criteria from international and national standards (ASTM, ISO). There is no "adjudication" in the sense of reconciling subjective expert opinions.

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

No. This document describes the non-clinical performance testing of a surgical glove, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not relevant or applicable.

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

Not applicable. This is a physical medical device (surgical glove), not a software algorithm. Therefore, "standalone algorithm-only performance" is not relevant.

7. Type of Ground Truth Used

The ground truth used for these tests is based on objective, standardized measurements and compliance with established performance criteria defined in international and national standards (ASTM D3577-09e, ASTM D5151-06, ASTM D6124-06, ASTM D6978-05, ISO 10993-10). These are quantifiable metrics (e.g., length, width, thickness, freedom from holes, residual powder, breakthrough detection time, biological response like irritation/sensitization).

8. Sample Size for the Training Set

Not applicable. This device is a physical product (surgical glove), not a machine learning model or algorithm that requires a "training set."

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

Not applicable, for the same reason as point 8.

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A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

Disposable Powder Free Vinyl Exam Gloves, With Aloe Vera, Green Color

This document is a 510(k) clearance letter for "Disposable Powder Free Vinyl Exam Gloves, With Aloe Vera Green Color." It does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The letter is a regulatory approval for a medical device (gloves), not an AI/ML product.

Therefore, I cannot provide the requested information based on the provided text.

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