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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.

These gloves were tested for use with chemotherapy drugs, fentanyl citrate and gastric acid as per ASTM D6978-05 (2023) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs:

The following drugs and concentration had NO breakthrough detected up to 240 minutes:

• Bendamustine HCl (5 mg/mL)
• Bleomycin Sulfate (15 mg/mL)
• Busulfan (6 mg/mL)
• Carboplatin (10 mg/mL)
• Carfilzomib (2 mg/mL)
• Cetuximab (Erbitux) (2 mg/mL)
• Chloroquine (50 mg/mL)
• Cisplatin (1 mg/mL)
• Cladribine (1 mg/mL)
• Cyclophosphamide (20 mg/mL)
• Cyclosporin A (100 mg/mL)
• Cytarabine HCl (100 mg/mL)
• Cytovene (10 mg/mL)
• Dacarbazine (10 mg/mL)
• Daunorubicin HCl (5 mg/mL)
• Decitabine (5 mg/mL)
• Docetaxel (10 mg/mL)
• Doxorubicin HCl (2 mg/mL)
• Epirubicin HCl (2 mg/mL)
• Etoposide (20 mg/mL)
• Fludarabine Phosphate (25 mg/mL)
• Fluorouracil (50 mg/mL)
• Fulvestrant (50 mg/mL)
• Gemcitabine HCl (38 mg/mL)
• Idarubicin HCl (1 mg/mL)
• Ifosfamide (50 mg/mL)
• Irinotecan HCl (20 mg/mL)
• Mechlorethamine HCl (1 mg/mL)
• Melphalan HCl (5 mg/mL)
• MESNA (100 mg/mL)
• Methotrexate (25 mg/mL)
• Mitomycin C (0.5 mg/mL)
• Mitoxantrone HCl (2 mg/mL)
• Oxaliplatin (2 mg/mL)
• Paclitaxel (6 mg/mL)
• Pemetrexed (25 mg/mL)
• Propofol (10 mg/mL)
• Raltitrexed (0.5 mg/mL)
• Retrovir (10 mg/mL)
• Rituximab (10 mg/mL)
• Temsirolimus (25 mg/mL)
• Topotecan HCl (1 mg/mL)
• Triclosan (1 mg/mL)
• Trisenox (Arsenic Trioxide) (1 mg/mL)
• Velcade (Bortezomib) (1 mg/mL)
• Vidaza (Azacitidine) (25 mg/mL)
• Vinblastine Sulfate (1 mg/mL)
• Vincristine Sulfate (1 mg/mL)
• Vinorelbine Tartrate (10 mg/mL)
• Zoledronic Acid (0.8 mg/mL)

The following chemotherapy drugs and concentration showed breakthrough detected in less than 60 minutes:

• Carmustine (3.3 mg/mL), breakthrough detected at 55.5 minutes
• Thiotepa (10 mg/mL), breakthrough detected at 50.8 minutes

Warning: Not recommended for use with Carmustine and Thiotepa

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

• Fentanyl Citrate Injection (100mcg/2mL)
• Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

The subject device, Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This product demonstrated reduced potential for sensitizing users to chemical additives, supported by a negative skin sensitization test (Modified Draize-95 Test) and tested for use with chemotherapy drugs, fentanyl citrate and gastric acid.

The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state.

The provided FDA 510(k) clearance letter and summary concern a medical device, "Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid." This document details the product's attributes, testing, and comparison to a predicate device for regulatory clearance.

However, the questions you've asked (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training set details) are highly specific to the performance of an AI/ML medical device rather than a physical product like examination gloves. The provided document describes the physical and chemical performance of the gloves (e.g., resistance to permeation by chemotherapy drugs, physical properties, biocompatibility, and skin sensitization), not the performance of an artificial intelligence or machine learning algorithm.

Therefore, many of your questions are not applicable to the information contained within this 510(k) clearance for medical gloves. I will answer the applicable questions based on the provided text, and explicitly state when a question is not relevant to this type of device.

Acceptance Criteria and Device Performance for Nitrile Examination Gloves

The "acceptance criteria" for these gloves are primarily physical, chemical, and biological performance standards, as demonstrated through various ASTM and ISO tests. The "reported device performance" indicates whether the gloves met these pre-defined standards.

1. Table of Acceptance Criteria and Reported Device Performance

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The Nitrile Powder Free Examination Gloves Biodegradable (Green) is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Nitrile Powder Free Examination Gloves Biodegradable (Green) meet all the requirements of ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are single use, disposable, and non-sterile. The gloves are offered in five sizes: S, M, L, XL, XXL.

The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves Biodegradable (Green). It describes the device, its intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document pertains to a medical device (examination gloves) that is a physical product, not an AI/software-based device. Therefore, several of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth) are not applicable in this context, as they relate specifically to the validation of AI/ML systems or diagnostic aids, not physical medical devices like gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for these gloves are primarily based on established ASTM and ISO standards for medical examination gloves and biocompatibility.

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

The document does not explicitly state the numerical sample size for each specific test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests are conducted according to recognized standards (ASTM, ISO), which inherently specify sampling plans and test methods (e.g., AQL 1.5 for hole detection typically implies a specific sampling size based on lot size).

• Data Provenance: The tests were conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd., located in Matang, Perak, Malaysia. The data appears to be prospective as it directly supports the 510(k) submission for this specific device.

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

Not Applicable. For a physical product like medical gloves, "ground truth" is established through standardized physical, chemical, and biological testing methods (e.g., measuring dimensions, tensile strength, or observing biological reactions in animal models), not through expert consensus on interpretations like with AI/imaging data. The standards themselves define the "ground truth" for compliance.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are relevant for subjective human assessments, particularly in image interpretation or clinical diagnosis. For physical and chemical property testing of gloves, the results are typically objective measurements or observations by trained laboratory personnel following the specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

Not Applicable. MRMC studies are used to evaluate the diagnostic performance of a system (often AI-assisted) by comparing human reader performance with and without the system. This is not relevant for a physical product like examination gloves.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not Applicable. "Standalone" performance refers to the diagnostic capability of an algorithm or AI without human interaction. This concept does not apply to a physical medical device. The device's performance is intrinsically linked to its physical and material properties.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements and observations derived from:

• Standardized Test Methods: Adherence to established and recognized international standards (e.g., ASTM D6319-19, ASTM D5151-19, ASTM D5511-18, ASTM D6124-06(2022), ISO 10993 series). These standards define the test procedures and acceptance criteria for various physical, chemical, and biological properties.
• Direct Physical and Chemical Analysis: Measurements of dimensions, tensile strength, elongation, residual powder, and observations of biodegradation and biocompatibility reactions.
• Biological Endpoints: For biocompatibility, the ground truth is based on the observed biological response (e.g., presence/absence of irritation, sensitization, or systemic toxicity) in established animal or in-vitro models as per ISO 10993.

8. The Sample Size for the Training Set

Not Applicable. The concept of a "training set" (for machine learning models) does not apply to the development or validation of a physical medical device like these gloves. The manufacturing process is controlled by quality management systems (e.g., 21 CFR Part 820 Quality System Regulation), and product performance is validated through testing of manufactured lots against specifications, not through machine learning.

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

Not Applicable. As mentioned above, there is no "training set" in the context of this device. The physical and performance characteristics are inherent to the material and manufacturing process, validated through testing against pre-defined standards.

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The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

This document pertains to the 510(k) submission for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528).

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

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

• Physical Dimensions, Physical Properties, Powder Residue, Freedom from Holes: The specific sample sizes are not explicitly stated within the provided text, but the tests were conducted according to ASTM and ISO standards (e.g., ISO 2859-1/S2/AQL 4.0 for dimensions, AQL 1.5 for freedom from holes), which prescribe sampling plans. The data provenance is from non-clinical tests conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd. No country of origin for the specific testing labs is provided, nor is it specified if the data is retrospective or prospective, though it's likely prospective for the submission.
• Irritation, Sensitization, Cytotoxicity, Acute systemic toxicity: The specific sample sizes for these biocompatibility tests are not explicitly stated in the document. These tests are likely performed ex vivo or in vivo with animal models (e.g., mice for acute systemic toxicity) or in vitro (e.g., for cytotoxicity). The data provenance is from non-clinical tests conducted by the manufacturer.
• Low Dermatitis Potential (Modified Draize): The specific sample size for the human repeat insult patch test (HRIPT) is not explicitly stated. The Modified Draize test (ASTM 6355-07) is a clinical test involving human subjects, therefore, the data provenance is clinical, likely from a prospective study.

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

This information is not provided in the document. The tests performed are primarily laboratory-based or standardized clinical tests with defined acceptance criteria, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or complex diagnostic tasks. The "ground truth" for these tests is the quantitative or qualitative outcome against a standard.

4. Adjudication method for the test set:

Not applicable. The tests performed are objective, standardized tests with predefined acceptance criteria. There is no mention or implication of a need for adjudication by multiple human experts for the results of these physical, chemical, or biological tests.

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 medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to this submission.

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

Not applicable. This device is a medical glove, not an algorithm or software.

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

The ground truth for most of these tests is based on objective measurements and established standards:

• Physical Properties (Dimensions, Tensile Strength, Elongation, Powder Residue, Freedom from Holes): Ground truth is based on quantitative measurements against the physical requirements specified in ASTM D6319-19, ASTM D412-16(2021), ASTM D6124-06(2022), and ASTM D5151-19.
• Biocompatibility (Irritation, Sensitization, Acute Systemic Toxicity): Ground truth is based on observations and measurements from standardized biological evaluations (ISO 10993 series) against set criteria for biological responses.
• Cytotoxicity: Ground truth is based on observable cellular responses in in vitro tests (ISO 10993-5).
• Low Dermatitis Potential (Modified Draize): Ground truth is based on the absence of clinical evidence of Type IV allergy in human subjects, as observed and reported in the HRIPT study, following ASTM 6355-07. This involves clinical observation in human subjects.

8. The sample size for the training set:

Not applicable. This is a physical medical device (gloves) and not an AI/ML-based algorithm that requires a training set.

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

Not applicable. As this device is a medical glove, it does not involve a training set or associated ground truth establishment for an AI/ML model.

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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.

These gloves were tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) are made from synthetic rubber latex. It is single use and powder-free. The subject device is a patient examination glove made from nitrile latex compound, Black and Orange color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-19, Standard specification for Nitrile Examination Gloves. The available sizes are Small, Medium, Large ,X-Large and XX-Large.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

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

The provided document lists various performance criteria for the Nitrile Powder Free Examination Gloves (Black and Orange) and reports the results against these criteria.

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

• Sample Size for Physical/Dimensional/Chemical Tests: For "Freedom From Holes," the sampling size is stated as 125 pieces (Ac: 7, Re: 8). The specific sample size for other physical/dimensional tests (length, width, thickness, tensile strength, elongation, residual powder content) is not explicitly stated, but the tests are reported as meeting ASTM D6319-19 and ASTM D6124-06 requirements. For Biocompatibility tests, no specific sample size is given, but the studies involve guinea pigs and rats, implying animal testing was conducted.
• Sample Size for Chemotherapy Drug Permeation Tests: Not explicitly stated within the document. The tests are reported as per ASTM D6978-05 (Reapproved 2019).
• Data Provenance: The manufacturing company is Dehai (Shandong) Medical Gloves, Co., Ltd. located in Zibo City, Shandong Province, China. The testing would presumably have been conducted in a laboratory, potentially in China or a third-party testing facility. The document doesn't specify if the data is retrospective or prospective, but testing of device performance characteristics is generally prospective for regulatory submissions.

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

Not applicable. This device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO). There is no "ground truth" established by human experts in the way an AI diagnostic algorithm would require. The "ground truth" is defined by the objective metrics and thresholds specified in the referenced ASTM and ISO standards.

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 establishing consensus ground truth in studies involving human interpretation (e.g., radiology reads). This document pertains to physical and chemical testing of a medical device against predefined standards, which does not involve such 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 document is for a medical glove, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is a medical glove, not an algorithm or AI system.

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 industry standards and objective material properties. Specifically:

• ASTM D6319-19: Standard specification for Nitrile Examination Gloves.
• ASTM D5151-19: Standard test methods for detection of holes in medical gloves.
• ASTM D6124-06: Standard test method for residual powder on medical gloves.
• ASTM D6978-05 (Reapproved 2019): Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
• ISO 10993-23, ISO 10993-10, ISO 10993-11: Biocompatibility standards for medical devices (Primary Skin Irritation, Skin Sensitization, Acute Systemic Toxicity).

These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough time for drugs).

8. The sample size for the training set

Not applicable. This device is a medical glove, 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 type of device.

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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)

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) Are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra 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.

Here's a breakdown of the acceptance criteria and study information for the Nitrile Powder Free Examination Gloves, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Chemotherapy Drug and Fentanyl Citrate Permeation (Breakthrough Detection Time - BDT)

Note on Permeation Acceptance: For chemotherapy drugs where the predicate device showed ">240 minutes", the proposed device also achieving ">240 minutes" indicates it meets or exceeds the previous performance. For Carmustine and Thiotepa, while the BDT is lower, the acceptance is ultimately related to the explicit warning not to use them with these drugs, indicating that the observed breakthrough times are treated as insufficient for safe handling.

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

The document does not specify the exact sample sizes used for each individual test against the acceptance criteria (e.g., number of gloves tested for each physical dimension, water leak, or permeation). However, it implies standardized testing according to relevant ASTM and ISO standards. The data provenance is industrial testing, most likely performed in a lab setting, to comply with the specified ASTM and ISO standards.

• Data Provenance: The device manufacturer, Better Care Plastic Technology Co., Ltd. (located in Shenze County, Hebei, China), would have overseen these tests, either internally or through a qualified testing laboratory. The data is thus of industrial origin, specifically from the manufacturer's testing or a third-party lab they used.
• Retrospective/Prospective: These are likely prospective tests conducted specifically for this 510(k) submission to demonstrate compliance with the standards.

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 examination gloves is established by objective, standardized laboratory tests (e.g., measuring physical dimensions, tensile strength, breakthrough detection time for chemicals, biological reactivity as per ISO standards). It does not involve human expert consensus on interpretations of images or clinical outcomes.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image-based diagnostic device evaluations where expert opinions need to be reconciled. For the physical and chemical testing of gloves, the results are quantitative measurements or direct observations (e.g., pass/fail for a water leak test) and do not require expert adjudication in the same sense.

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. An MRMC study assesses the performance of human readers (e.g., radiologists, pathologists) in interpreting medical data, often with and without AI assistance, across a range of cases. This device (examination gloves) is a physical product and does not involve human readers or AI assistance in its primary function, nor in the testing performed for its clearance.

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

This is not applicable. This question pertains to AI/algorithm performance. The device is a physical product, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance of these gloves is defined by:

• Standardized Test Methods and Specifications: Specific values and criteria (e.g., minimum tensile strength, maximum powder residue, minimum breakthrough detection time) defined by national and international standards like ASTM D6319-19, ASTM D6978-05, ISO 10993 series.
• Direct Measurement and Observation: The device's physical properties and chemical resistance are directly measured and observed in laboratory settings according to these established protocols.
• Biological Reactivity Endpoints: For biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity), the "ground truth" is determined by established biological endpoints and criteria within the ISO 10993 standards.

8. The sample size for the training set

This is not applicable. This question refers to the training data for an AI algorithm. This device is a physical medical product, and no AI algorithm development is described or relevant to its clearance.

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

This is not applicable for the reasons stated in point 8.

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Nitrile powder free 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.

Nitrile powder free 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. This glove is in blue color, non-sterile and can be available in four specifications: Small, Medium, Large, X meets all of the requirements of ASTM standard D 6139-19.

The provided document is a 510(k) Premarket Notification for Nitrile Powder Free Examination Gloves (YK0001). It addresses the substantial equivalence of the device to a legally marketed predicate device. This type of submission focuses on demonstrating that the new device is as safe and effective as a predicate device, often through performance testing against established standards, rather than through extensive clinical trials for new medical technologies.

Therefore, the study design described in the prompt, addressing AI performance, MRMC studies, and detailed ground truth establishment, is not applicable to this specific medical device (examination gloves). The document details the physical and chemical properties of the gloves and their compliance with relevant ASTM and ISO standards.

Here's the information extracted that aligns with the prompt's request for acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI medical device (Nitrile Powder Free Examination Gloves). The acceptance criteria are based on established national and international standards for medical gloves.

• Small: ≥230mm
• Medium: ≥230mm
• Large: ≥230mm
• X large: ≥230mm
  Width (mm):
• Small: 85±10mm
• Medium: 95±10mm
• Large: 110±10mm
• X large: 115±10mm
  Thickness (mm) Finger:
• Small: ≥0.05mm
• Medium: ≥0.05mm
• Large: ≥0.05mm
• X large: ≥0.05mm
  Thickness (mm) Palm:
• Small: ≥0.05mm
• Medium: ≥0.05mm
• Large: ≥0.05mm
• X large: ≥0.05mm | Length (mm):
• Small: 231-238/Pass
• Medium: 244-248/Pass
• Large: 245-249/Pass
• X large: 240-244/Pass
  Width (mm):
• Small: 85-86/Pass
• Medium: 96-97/Pass
• Large: 106-108/Pass
• X large: 113-114/Pass
  Thickness (mm) Finger:
• Small: 0.097-0.111/Pass
• Medium: 0.110-0.131/Pass
• Large: 0.110-0.129/Pass
• X large: 0.116-0.128/Pass
  Thickness (mm) Palm:
• Small: 0.064-0.068/Pass
• Medium: 0.065-0.069/Pass
• Large: 0.060-0.065/Pass
• X large: 0.059-0.066/Pass |
  | ASTM D5151 | Watertightness Test for Detection of Holes | No water leakage (Inspection Level I, AQL 2.5, as per ASTM D6319-19 and 21 CFR 800.20) | 0/125/Pass |
  | ASTM D6124 | Powder Content |

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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.

Two subject devices are bundled into this 510(k) submission. The subject devices, the Nitrile Powder Free Examination Gloves and the Chemotherapy Nitrile Powder Free Examination Gloves, are single use, disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The gloves are made of nitrile rubber, powder free, ambidextrous with beaded cuff and tested for use with chemotherapy drugs. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that facilitates the user in donning the gloves without using lubricant and donning powder on the glove surface. These gloves are offered in six sizes (XS, S, M, L, XL, XXL), and supplied in non-sterile state. The two subject devices proposed are identical in terms of sizes, materials, color, specification, and process. The only difference between the two is the chemotherapy drug labeling.

The provided document is a 510(k) summary for Nitrile Powder Free Examination Gloves and Chemotherapy Nitrile Powder Free Examination Gloves. It details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.

Crucially, this document is for a Class I medical device (gloves) and explicitly states that "Clinical data is not required for marketing clearance of patient examination gloves." Therefore, there are no acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance related to an AI/ML device as none of this applies to the product described.

Instead, the document focuses on demonstrating that the gloves meet established performance standards for physical properties, barrier integrity, and biocompatibility.

Here's an analysis based on the information provided, specifically highlighting why the requested AI/ML-related information is absent and what was evaluated:

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

The document provides tables of non-clinical tests and their requirements, which serve as the acceptance criteria for these physical and chemical properties.

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

The document does not explicitly state the sample sizes used for each specific non-clinical test (e.g., how many gloves were tested for watertightness, or how many samples for biocompatibility). The tests are standardized (ASTM, ISO), meaning they have established sample size requirements for their methodologies, but the specific numbers are not presented in this summary.

Data provenance: The tests were performed by the manufacturer (KL-Kepong Rubber Products Sdn. Bhd. in Malaysia) or accredited labs they contracted. The data is prospective, generated specifically for this submission.

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

Not applicable. This is not an AI/ML device; therefore, there is no "ground truth" to be established by experts in the context of clinical interpretation or diagnosis. The ground truth for these device properties is based on adherence to established international (ISO) and national (ASTM) standards and laboratory testing protocols.

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

Not applicable. There is no subjective interpretation or diagnostic outcome to adjudicate for this type of device. The tests are objective and quantitative measurements against predefined specifications.

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" for this device's performance is objective and defined by established industry and regulatory standards for physical properties (e.g., dimensional measurements, tensile strength, elongation, freedom from holes, residual powder) and chemical resistance/biocompatibility via standardized testing protocols (e.g., ASTM D6978 for chemotherapy drug permeation, ISO 10993 for biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "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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The powder-free 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.

Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange

The provided document is an FDA 510(k) clearance letter for Nitrile Powder Free Examination Gloves. This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for software or AI-powered medical devices.

The letter pertains to a Class I medical device (non-powdered patient examination glove), which is a physical product, not a software or AI-driven diagnostic or therapeutic tool. As such, the clearance process for such a device typically involves demonstrating substantial equivalence to a predicate device based on material properties, performance standards (e.g., tensile strength, barrier integrity), and biocompatibility, rather than algorithms, ground truth establishment, or human-in-the-loop studies.

Therefore, I cannot extract the requested information from the provided text because it describes the clearance of examination gloves, not an AI/software medical device.

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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. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs

The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs. The gloves are offered in four sizes: small, medium, large, and extra-large.

This is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs. This document does not describe the acceptance criteria and study for an AI/ML device. Instead, it focuses on the performance characteristics of medical gloves, particularly their resistance to chemotherapy drugs.

Here’s a breakdown of the information provided, re-interpreting some fields for a non-AI/ML medical device where applicable, and highlighting what is missing in the context of your request for an AI/ML device:

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

The document provides several tables detailing the performance of the gloves.

Permeation by Chemotherapy Drugs (Key Performance Claim):

Other Non-Clinical Testing Results (from Table 2 and Table 3):

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 for Chemo Permeation: Not explicitly stated as a single number. The testing is done "in accordance with ASTM D6978-05" which specifies test methods. While not clearly itemized in the summary, typical ASTM D6978 testing involves multiple specimens per drug.
• Sample Size for Biocompatibility: Not explicitly stated, but standard ISO 10993 tests involve specific numbers of samples/animals or cell cultures as per the standard.
• Sample Size for Physical Tests (e.g., Holes, Dimensions, Tensile Strength): For "Freedom from Holes," the results show "S:0/125 leaks", "M:0/125 leaks", "L:0/125 leaks", "XL:0/125 leaks," implying a sample size of 125 gloves per size for this test. Other physical tests (dimensions, tensile strength) are usually performed on a representative sample set as per the ASTM standards.
• Data Provenance: Not specified whether the tests were conducted in China (where the manufacturer is located) or another country. The testing methods used are international ASTM and ISO standards. It's a prospective series of tests conducted on the manufactured device.

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 section is Not Applicable to this type of device (medical gloves). The "ground truth" for medical gloves is established through objective physical and chemical testing against recognized national and international standards (ASTM, ISO), not through expert clinical consensus or interpretation of medical images.

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

This is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human readers/interpreters to resolve discrepancies, typically for AI/ML diagnostic tools. For physical devices like gloves, performance is measured objectively against predefined 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

This is Not Applicable. An MRMC study is relevant for AI/ML diagnostic or assistive technologies where human readers are involved in interpretation. This document describes physical, non-AI/ML device performance.

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

This is Not Applicable. This device is not an algorithm or AI.

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

The "ground truth" for this device is established by:

• Objective physical measurements: e.g., length, width, thickness, tensile strength, elongation, powder content.
• Objective chemical permeation testing: measuring breakthrough time of chemotherapy drugs using analytical methods as specified in ASTM D6978-05.
• Biocompatibility assays: in-vitro (cytotoxicity) and in-vivo (irritation, sensitization) tests as per ISO 10993 standards.

These are validated laboratory test methods, not expert consensus or clinical outcomes data in the usual sense for diagnostic devices.

8. The sample size for the training set

This is Not Applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions pertain to physical performance testing of a manufactured product.

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

This is Not Applicable. As it's not an AI/ML device, there is no training set or corresponding ground truth establishment process in the context of your request.

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Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.

These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

This document is an FDA clearance letter for Nitrile Powder Free Examination Gloves. It focuses on the device's substantial equivalence to predicate devices and its testing against chemotherapy drugs and fentanyl citrate. The document is primarily regulatory and does not contain information about an AI/ML device study or its performance. Therefore, I cannot provide the requested details regarding acceptance criteria and a study proving an AI/ML device meets them.

The provided text pertains to a medical device clearance for examination gloves and does not contain any information about an AI/ML device, its acceptance criteria, or a study to evaluate its performance.

Therefore, I cannot answer your request based on the provided input.

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