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The Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) is a disposable device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

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This document is a 510(k) clearance letter from the FDA for Powder Free Polyurethane Examination Gloves. It is not a document describing an AI/ML-driven medical device or software. Therefore, the information requested in your prompt (acceptance criteria, study details for AI/ML performance, ground truth establishment, etc.) cannot be extracted from this letter.

This letter confirms that the gloves are "substantially equivalent" to legally marketed predicate devices, meaning they meet the safety and effectiveness standards for their intended use as barrier protection. The "study" here refers to the documentation and evidence the manufacturer provided to demonstrate this substantial equivalence based on established performance characteristics for medical gloves (e.g., barrier integrity, tensile strength, biocompatibility), not an AI/ML efficacy study.

To answer your prompt, I would need a document related to the clearance of an AI/ML medical device, which typically includes detailed performance studies and acceptance criteria related to its algorithmic accuracy and clinical utility.

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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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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 and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all current specifications listed under the ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application and comply with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978-05. The powder-free gloves are made from Nitrile (NBR) latex and are green in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only. The product is not manufactured using natural rubber latex.

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

This document is a 510(k) clearance letter for medical examination gloves and contains no information about an AI/ML powered device. Therefore, it's impossible to extract the requested information related to acceptance criteria, study details (sample sizes, data provenance, expert ground truth), MRMC studies, or standalone algorithm performance.

The provided text focuses on the performance characteristics of gloves (e.g., resistance to chemotherapy drugs, physical dimensions, biocompatibility) and their substantial equivalence to a predicate device.

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Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.

This document is a 510(k) clearance letter for medical examination gloves. It is not a document describing a study for a medical device that uses AI or requires expert ground truth. Therefore, I cannot provide the requested information.

The prompt specifically asks for details related to:

• A table of acceptance criteria and device performance for an AI/ML device.
• Sample sizes for test and training sets (relevant to AI/ML).
• Number and qualifications of experts for ground truth (relevant to AI/ML).
• Adjudication methods (relevant to AI/ML).
• MRMC studies (relevant to AI/ML).
• Standalone algorithm performance (relevant to AI/ML).
• Type of ground truth used (relevant to AI/ML).
• How ground truth was established for training (relevant to AI/ML).

The provided text discusses the non-clinical performance testing of rubber examination gloves. The "acceptance criteria" and "results" tables in the document pertain to physical and chemical properties of gloves (e.g., length, width, thickness, tensile strength, protein content, biocompatibility) tested against established ASTM and ISO standards for medical gloves.

There is no mention of an algorithm, AI, machine learning, human-in-the-loop performance, or expert review for diagnostic purposes. The "ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established industry standards, not expert interpretations of medical images or data.

Ask a specific question about this device

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

Non-Sterile Nitrile Patient Examination Glove is made from synthetic rubber latex. It is single use and powder-free class I Nitrile Patient Examination Gloves which coated by on-line polymer with mild on-line chlorination process. These processes modify the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder. The available sizes are X-Small, Small, Medium, Large and X-Large. The Nitrile Examination Gloves Powder Free (Blue & Black) have been tested for Chemotherapy Drugs. The subject devices are identical in design and formulation to the predicate gloves of K230121.

The provided FDA 510(k) clearance letter pertains to Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black), a medical device. This type of device is classified as a Class I medical device and does not involve AI/ML technology. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert qualifications, adjudication methods, effect sizes) are not applicable.

The acceptance criteria and device performance are primarily evaluated based on material properties, chemical permeation resistance, and biocompatibility, using established ASTM and ISO standards for examination gloves.

1. Table of Acceptance Criteria and Reported Device Performance

The device, "NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)", was tested against various physical, chemical, and biological criteria.

Detailed Chemotherapy Drug and Fentanyl Citrate Permeation Performance:

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

The document does not explicitly state the exact sample sizes for each test (e.g., number of gloves tested for permeation, holes, dimensions, etc.) but refers to adherence to the methodologies outlined in the specified ASTM and ISO standards. These standards typically define minimum sample sizes for material testing.

• Data Provenance: The document states the applicant is from Malaysia (Careglove Global Sdn. Bhd.). The testing was conducted according to international standards (ASTM, ISO), implying the tests were performed in a controlled laboratory environment, likely by the manufacturer or a contracted lab. The data is non-clinical and derived from prospective testing of manufactured glove samples.

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

Not applicable. This device is not an AI/ML device that requires expert review for "ground truth" establishment in the context of diagnostic or interpretive tasks. The "ground truth" for material properties is established by the physical and chemical measurements themselves, according to standardized protocols and certified laboratory equipment.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML device that requires adjudication for interpretations. Test results are objective measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are relevant for diagnostic or interpretive AI/ML devices where human readers' performance is evaluated with and without AI assistance. This is a physical and chemical barrier device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This device is a passive physical barrier and does not involve any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements of physical properties (e.g., length, thickness, tensile strength, elongation), chemical resistance (breakthrough detection time), and biological reactivity (biocompatibility tests), as defined by internationally recognized standards (ASTM, ISO). There is no subjective human "ground truth" in this context.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that undergoes "training."

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

Not applicable. This is not an AI/ML device. The manufacturing process of the gloves is designed to meet the specified standards, and quality control ensures consistency, but this is not "training" in the context of AI/ML.

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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.

Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. 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. The gloves are single use, disposable, and provided non-sterile.

Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The device in question is "Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K242533).

Non-Clinical Performance Data

Clinical Performance Data

Study Information

Due to the nature of the device (patient examination gloves) and the provided documentation, several sections of your request are not directly applicable or explicitly detailed. This document is a 510(k) summary for a Class I medical device, which typically relies more on performance testing against established standards and equivalence to predicates rather than complex clinical trials like those for novel therapeutic devices.

Here's what can be extracted from the document:

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

   • Permeation Tests (ASTM D6978-05): The document does not specify the exact sample size used for the permeation tests for each chemical. The standard ASTM D6978-05 typically outlines the number of replicates required (e.g., three specimens).
   • Biocompatibility Tests (ISO 10993 series): Similarly, the sample sizes for these tests are not explicitly stated in the summary but would be specified by the respective ISO standards.
   • Clinical Test (Modified DRAIZE-95 Test): A 305-subject study was completed. The country of origin and whether it was retrospective or prospective is not specified, but such a test is typically prospective to evaluate a new or modified device.
   • Data Provenance: The document generally refers to testing "under the conditions of this study," without specifying the country of origin for non-clinical tests. The manufacturer is based in China.

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

   • For the non-clinical tests (physical properties, chemical permeation, biocompatibility), the "ground truth" is established by the standardized methods themselves (ASTM and ISO standards) and objective measurements by qualified laboratory personnel. The number of "experts" and their specific qualifications beyond standard lab certifications are not typically detailed in these summaries.
   • For the clinical test on dermatitis potential, the "ground truth" is derived from the subjects' reactions as evaluated by the study investigators. The qualifications of these investigators are not provided.

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

   • For the non-clinical tests, adjudication methods like 2+1 or 3+1 are not applicable. Results are based on objective measurements against defined criteria.
   • For the clinical test (Modified DRAIZE-95), the document does not specify an adjudication method. Clinical studies of this nature usually involve clinical investigators observing and documenting reactions, and a statistical analysis of the aggregate results.

4. 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 physical product (gloves), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

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

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

   • Physical and Chemical Tests: The ground truth is based on the objective measurements of the glove's properties (dimensions, strength, elongation, watertightness, powder residue) and breakthrough detection times for chemicals, all conducted according to recognized ASTM and ISO standards.
   • Biocompatibility Tests: Ground truth is determined by the biological response observed in in vitro (cytotoxicity) or in vivo (irritation, sensitization, acute systemic toxicity) models as interpreted against the acceptance criteria of the ISO 10993 standards.
   • Dermatitis Potential Clinical Test: The ground truth is the observed clinical reactions of human subjects to the device, evaluated against criteria for allergic contact sensitization.

7. The sample size for the training set:

   • Not applicable. This pertains to an algorithm or machine learning model. This device is a physical product.

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

   • Not applicable. As above, this is for an algorithm or machine learning model.

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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, Fentanyl Citrate and Other Select Drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs 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 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate and Select Other Drugs as per ASTM D6978. The gloves are single use, disposable, and non-sterile.

Here's a breakdown of the acceptance criteria and study information for the Powder Free Nitrile Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for length, width, thickness, etc.). However, the tests were conducted according to established ASTM and ISO standards, which typically specify appropriate sample sizes for such evaluations.

• Provenance: This information is not directly stated. The tests were conducted according to international standards (ASTM and ISO). The manufacturing company is Lingshi Hongruida Health Protection Technology Co., Ltd. located in Jinzhong, Shanxi, China. It is highly probable that the testing was performed in a laboratory either in China or an accredited facility capable of performing these international standard test methods. The study appears to be retrospective as it involves the testing of a finished device against established performance criteria.

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

This information is not applicable. The device is a physical product (nitrile gloves), and its performance is evaluated against objective, measurable criteria defined by established engineering and biological safety standards (ASTM and ISO), not subjective expert interpretation of medical images or patient data. The "ground truth" is derived from direct measurements and laboratory analyses, not expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable. As the testing involved objective physical and chemical performance standards, there was no need for expert adjudication. The results were quantifiable measurements against pre-defined acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices involving human interpretation of medical data (e.g., radiologists reading images). This product is a medical glove, and its effectiveness is determined through standardized physical, chemical, and biological testing.

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

Yes, the studies conducted are standalone performance evaluations of the physical glove itself, without any human-in-the-loop component in the evaluation of its core performance characteristics (e.g., tensile strength, resistance to chemical permeation, cytotoxicity). The testing directly measured the attributes of the glove.

7. The Type of Ground Truth Used:

The ground truth for this device's performance evaluation is based on established objective technical standards and laboratory measurements. Specifically:

• Physical properties (length, width, thickness, tensile strength, elongation) are measured directly according to ASTM D6319-19 and ASTM D412-16(2021).
• Chemical resistance (chemotherapy drug permeation) is measured according to ASTM D6978-05 (Reapproved 2019).
• Biocompatibility (skin sensitization, irritation, cytotoxicity, systemic toxicity) is evaluated through laboratory tests following ISO 10993 series standards.
• Freedom from holes is evaluated by ASTM D5151-19.
• Powder residue is evaluated by ASTM D6124-06 (Reapproved 2022).

8. The Sample Size for the Training Set:

This information is not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and quality control would involve statistical sampling typical for medical device production.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The 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.

The glove was tested for use with chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2023).

The subject device is single use, disposable and non-sterile gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder free, ambidextrous with beaded cuff, Blue/Black colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in six sizes: XS, S, M, L, XL, XXL.

This FDA 510(k) summary describes the acceptance criteria and the study results for the Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242936).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Black Gloves:
Carmustine: 22.6 min
Cisplatin: >240 min
Cyclophosphamide: >240 min
Dacarbazine: >240 min
Doxorubicin HCL: >240 min
Etoposide: >240 min
Fluorouracil: >240 min
Methotrexate: >240 min
Paclitaxel: >240 min
Thiotepa: 35.6 min
Fentanyl Citrate: >240 min |
| ISO 10993 Part 10-2021 - Biocompatibility | | | |
| Skin Sensitization Testing | Skin Sensitization Testing | Under the conditions of the study, the device is not a sensitizer | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test. |
| ISO 10993 Part 23-2021 - Biocompatibility | | | |
| Skin Irritation Testing | Skin irritation Testing | Under the conditions of the study, the device is not an irritant | The test article met the requirements of the test since the difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.0 for the SC and SO test article extracts, respectively. |
| ISO 10993-5:2009 - Biocompatibility | | | |
| Cytotoxicity testing | Cytotoxicity testing | No Cytotoxicity reactivity (note: text says "No Cytotoxicity reactivity" but result section shows some initial toxicity addressed by further testing) | The test article extract showed evidence of causing severe cell lysis or toxicity. Toxicity concerns was addressed by Acute Systemic Toxicity testing. |
| ISO 10993-11:2017 - Biocompatibility | | | |
| Acute systemic toxicity study | Acute systemic toxicity study | Subject showed no adverse biological reaction | There was no mortality or evidence of systemic toxicity from the extracts injected into mice. Each test article extract met the requirements of the study. |

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

The document does not explicitly state the sample sizes for the test sets for each specific test (e.g., how many gloves were tested for length, how many for water leak). However, the standard ASTM D6319-19(2023) and other listed standards would define the required sample sizes for each test to ensure statistical validity.

The data provenance is not explicitly stated in terms of country of origin of the data or retrospective/prospective. However, the tests are "non-clinical tests" conducted to verify design specifications and conform to international and national standards (ASTM, ISO). This suggests the data was generated through controlled laboratory testing following these specified methodologies.

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

This device is a medical glove, and its performance evaluation primarily relies on objective, standardized laboratory tests against defined physical, chemical, and biological endpoints, not subjective expert assessment of images or clinical cases. Therefore, the concept of "experts establishing ground truth for a test set" as typically understood in AI/imaging studies does not apply here. The "ground truth" for these tests is the quantitative measurement results compared to the established thresholds defined by the standards.

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

Not applicable. As mentioned above, the evaluation relies on objective analytical tests rather than subjective human assessment requiring adjudication.

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

Not applicable. This device is a medical glove, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for the performance evaluation of these gloves is based on objective measurements and chemical analysis as defined by the referenced ASTM and ISO standards. For example:

• Physical properties (length, width, thickness, tensile strength, elongation): Measured values compared to a numerical range or minimum defined by ASTM D6319.
• Freedom from holes (water leak test): Objective criteria (AQL 2.5) for defect detection.
• Powder residue: Quantitative measurement (Max 2mg/glove).
• Chemical permeation (chemotherapy drugs and Fentanyl Citrate): Directly measured breakthrough detection time (BDT) in minutes, as per ASTM D6978.
• Biocompatibility (Sensitization, Irritation, Cytotoxicity, Systemic Toxicity): Laboratory test results demonstrating lack of adverse biological reactions as defined by ISO 10993 standards and evaluated against established pass/fail criteria (e.g., no evidence of sensitization, no irritancy, no mortality/toxicity).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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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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NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.

Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)

The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes

Warning: Not for Use with: Carmustine, ThioTEPA

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). However, for the watertightness test (ASTM D5151/ASTM D6319), it reports "0/125/Pass" which indicates a sample size of 125 gloves were tested for holes, and none failed.

The non-clinical tests were conducted to verify that the proposed device met all design specifications according to recognized standards. The identity of the testing laboratories or the origin of the samples is not specified in this document.

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

This document describes non-clinical performance testing of a physical device (gloves). Therefore, there is no "ground truth" derived from expert interpretation of medical images or data in the typical sense. The ground truth for these tests is established by the specified standards (ASTM and ISO standards) themselves, which outline quantitative metrics and methodologies for evaluation. No human experts are explicitly mentioned as establishing ground truth for these specific tests.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective, quantitative measurements against established standards, not subjective assessments requiring adjudication or consensus among experts.

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

No. An MRMC comparative effectiveness study is not applicable to the non-clinical performance testing of medical gloves. This type of study is typically used for evaluating the effectiveness of diagnostic or prognostic medical devices that rely on human interpretation, often with AI assistance, in comparison to human interpretation alone.

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

Not applicable. This document pertains to the physical performance of medical gloves, not a software algorithm that would operate in a standalone mode.

7. Type of Ground Truth Used

The ground truth for all tests is based on established testing standards and their quantitative acceptance criteria. For example:

• Physical dimensions are compared against numerical ranges specified in ASTM D6319-19.
• Watertightness is assessed by the absence of holes per ASTM D5151-19, with an acceptable quality level (AQL).
• Powder content is measured against a maximum limit per ASTM D6124-06.
• Tensile strength and ultimate elongation are measured against minimum requirements per ASTM D6319-19.
• Chemotherapy drug permeation is determined by breakthrough detection times as per ASTM D6978-05(2023).
• Biocompatibility tests (cytotoxicity, irritation, sensitization, acute systemic toxicity) are evaluated according to ISO 10993 series standards.

8. Sample Size for the Training Set

Not applicable. This document is about a physical medical device (gloves) and its non-clinical performance testing, not an AI/ML-based device that requires a training set.

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

Not applicable, as there is no training set for this device.

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