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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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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, 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.

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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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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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The Powder Free Nitrile Examination Gloves (Blue) , Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 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 tested chemotherapy drugs are: Carmustine 3.3 mg/ml(3,300 ppm) 27.7 (35.5,27.7,27.7) Cisplatin 1 mg/ml (1,000 ppm) >240min Cyclophosphamide 20 mg/ml (20,000 ppm) >240min Dacarbazine 10mg/ml (10,000 ppm) >240min Doxorubicin HCl 2 mg/ml(2,000 ppm) >240min Etoposide 20 mg/ml (20,000 ppm) >240min Fluorouracil 50mg/ml(50,000 ppm) >240min Gemcitabine HCl 38 mg/ml (38,000 ppm) >240min Ifosfamide 50mg/ml (50,000 ppm) >240min Methotrexate 25mg/ml (25,000 ppm) >240min Mitomycin C 0.5 mg/ml(500 ppm) >240min Mitoxantrone HC1 2 mg/ml (2,000 ppm) >240min Paclitaxel 6 mg/ml (6,000 ppm) >240min Thiotepa 10 mg/ml (10,000 ppm) 59.4(67.5,59.4,65.9) Vincristine Sulfate 1 mg/ml (1,000 ppm) > 240min The tested non-chemotherapy drugs are: Fentanyl Citrate injection 100mcg/2ml >240min Note: Carmustine and Thiotepa have extremely low permeation times of 27.7 and 59.4 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa

The Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are blue color, powder free, nitrile gloves. The gloves are offered in six sizes: XS、S、M、L、XL、XXL, packed in a paper box.

The proposed gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978-05. The proposed device was modification from the legally marketed (existing) device "Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue)"/K202356, manufactured by "KANGLONGDA VIETNAM PROTECTION TECHNOLOGY COMPANY LIMITED", same as the sponsor of this submission.

There are two modifications, one is to add a large model XXL, and the other is to add the "Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" indications for use than the legally marketed (existing) device. Testing has been conducted on the proposed device passed as per ASTM D6978-05, ASTM D6319-19, ASTM D5151-19, ASTMD 6124-06.

The materials and the manufacturing process technology are the same.

The provided document (a 510(k) summary for medical gloves) does not contain information about a study that proves a device meets acceptance criteria related to AI/ML or human reader performance. The document is for "Powder Free Nitrile Examination Gloves" and pertains to mechanical and material properties, as well as resistance to chemical permeation.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample size used for a test set or data provenance for an AI/ML device.
3. Number of experts used to establish ground truth or their qualifications for an AI/ML device.
4. Adjudication method for an AI/ML device test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study for human readers with and without AI.
6. Standalone performance of an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
8. Sample size for the training set of an AI/ML device.
9. How the ground truth for an AI/ML training set was established.

However, based on the document, I can present the acceptance criteria and performance for the glove device as non-clinical testing.

Acceptance Criteria and Study for Powder Free Nitrile Examination Gloves

This document describes the non-clinical testing performed on "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" to demonstrate its safety and effectiveness.

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

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

• The document does not specify the exact sample sizes (e.g., number of gloves tested for each attribute) for the physical and chemical resistance tests. It only states that tests were conducted according to the listed ASTM and ISO standards.
• Data Provenance: The testing was conducted to verify that the device meets design specifications and complies with international standards. The origin of the testing data is not explicitly stated beyond being "non-clinical tests."

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

• This is not applicable as the device is a medical glove, not an AI/ML diagnostic or prognostic tool. Ground truth is established by objective physical and chemical measurements following established standards, not by expert consensus or physician reads.

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

• Not applicable for this type of device testing.

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 as 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 as this is not an AI/ML device.

7. The type of ground truth used:

• For the physical properties (dimensions, watertightness, tensile strength, powder content), the ground truth is based on direct physical measurement and standard test methods outlined in ASTM standards.
• For chemical permeation (chemotherapy drugs and Fentanyl), the ground truth is established by analytical measurement of breakthrough time according to ASTM D6978-05.
• For biocompatibility (irritation, sensitization, cytotoxicity), the ground truth is established by biological assays according to ISO 10993 standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. The "training" for glove manufacturing relates to process control and material specifications, not a data-driven model.

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

• Not applicable as this is not an AI/ML device.

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Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Not Found

This document is an FDA 510(k) clearance letter for "Disposable Medical Nitrile Examination Gloves (Non sterile)". This type of medical device is a Class I device and does not involve AI/ML components for diagnosis or treatment. The content of this letter focuses on regulatory compliance for a physical product, not on the performance of a software algorithm.

Therefore, the requested information about acceptance criteria, study data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc., are not applicable to this document. These details are typically required for AI/ML-driven medical devices that output algorithmic decisions or analyses, not for physical examination gloves.

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Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The difference between the devices is the color of powder free green nitrile examination gloves is green, the color of powder free pink nitrile examination gloves is pink, the color of powder free purple nitrile examination gloves is purple. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The medical device in question is the "Powder Free Green/Pink/Purple Nitrile Examination Gloves." The documentation provided describes the acceptance criteria and the non-clinical studies performed to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

• Length (mm): XS/S/M/L/XL: ≥230
• Width(mm): XS: 70±10mm; S: 85±10mm; M: 95±10mm; L: 110±10 mm; XL: 120±10 mm
• Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Physical Dimensions:
• Length(mm): XS/S/M/L/XL: 236~239 (Pass)
• Width(mm): XS 70; S 8586; M 9596; L 110~112; XL 120 (Pass)
• Finger: 0.23~0.47 (Pass)
• Palm: 0.26~0.46 (Pass) |
  | ASTM D5151-19 | Watertightness Test for Detection of Holes:
• Be free from holes when tested in accordance with ASTM D5151 | Pass |
  | ASTM D412 | Physical Properties:
• Before Aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 500% min
• After Aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 400% min | Physical Properties:
• Before Aging: Tensile Strength: 20.1628.78MPa (Pass); Ultimate Elongation: 522558% (Pass)
• After Aging: Tensile Strength: 18.2520.39MPa (Pass); Ultimate Elongation: 525555% (Pass) |
  | ASTM D6124 | Powder Content:
• Meet the requirements of Less than 2mg per glove | ≤0.46mg (Pass) |
  | ISO 10993-10 | Irritation:
• Non-irritating | Under the conditions of the study, not an irritant. |
  | ISO 10993-11 | Acute systemic toxicity:
• Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. |
  | ISO 10993-23 | Sensitization:
• Non-sensitizing | Under the conditions of the study, not a sensitizer. |

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

The document does not explicitly state the sample sizes for each specific test within the non-clinical studies. However, the tests were conducted according to recognized international and national standards (ASTM and ISO). The provenance of the data is not specified beyond indicating that the studies were performed as part of the regulatory submission process for the manufacturer, Hebei Titans Hongsen Medical Technology Co., Ltd. in China. These studies are typically prospective tests conducted on representative samples of the manufactured devices.

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

Not applicable. The ground truth for these types of devices (examination gloves) is established by performance against pre-defined, objective physical, chemical, and biological criteria outlined in the referenced standards (ASTM, ISO). Expert consensus is not typically used to establish ground truth for these quantitative, standardized tests.

4. Adjudication Method for the Test Set:

Not applicable. As the tests are based on objective, standardized measurements against specified criteria, an adjudication method for test results is not typically required. The results are quantitative and compared directly to the predetermined acceptance limits.

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

No. This type of study is not applicable for examination gloves, which are physical barriers designed for medical purposes. MRMC studies are typically used for diagnostic devices that involve human interpretation or decision-making aided by AI.

6. Standalone Performance Study:

Yes, a standalone study was performed. The non-clinical tests described (physical dimensions, watertightness, physical properties, powder content, biocompatibility) assess the performance of the device itself (the gloves) against established standards. This represents the standalone performance of the algorithm (in this context, the gloves as a product) without human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

The ground truth used for the non-clinical tests is based on pre-established, objective criteria and limits defined within recognized international and national standards (e.g., ASTM D6319-19, ASTM D5151-19, ISO 10993 series). These standards outline the acceptable ranges for physical properties and the expected biological responses.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical product (gloves) whose performance is evaluated through non-clinical testing against established standards.

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

Not applicable, as there is no training set for a physical device like examination gloves.

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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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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 select other drugs using ASTM D6978-05(2019)

Powder Free Nitrile Examination Gloves (Blue), 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, 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, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.

The provided document describes the acceptance criteria and performance of "Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs" (K240051).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison (Proposed Device K240051):

Warning: Do not use with Carmustine and Thiotepa due to "extremely low permeation times" (29.1 minutes and 78.3 minutes, respectively).

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

• The document primarily refers to standard ASTM and ISO test methodologies for device performance (e.g., ASTM D6319-19, ASTM D6978-05(2019), ISO 10993 series). These standards typically define the sample sizes required for each specific test to ensure statistical validity.
• Data Provenance: The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The tests were performed by Lingshi Hongruida Health Protection Technology Co., Ltd. located in China. The data is retrospective in the sense that the testing was performed and then submitted with the 510(k) application. Specific details on exact sample sizes (e.g., number of gloves tested for each characteristic) within each standard are not explicitly detailed in this summary for every test. However, the chemotherapy drug permeation testing likely involved multiple samples per drug as per ASTM D6978.

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

• This information is not applicable as the device is a physical medical device (examination glove) and the testing involved objective, quantitative, and standardized measurements according to established consensus standards (ASTM, ISO). There were no "experts" establishing a "ground truth" in the way they would for, say, image interpretation or clinical diagnosis. The ground truth for performance relied on the specified chemical and physical property measurements.

4. Adjudication method for the test set:

• This is not applicable. As mentioned above, the testing involved objective physical and chemical measurements governed by established standards, not subjective interpretations 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:

• This is not applicable. This device is an examination glove, not an AI-powered diagnostic tool or imaging software. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant.

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

• This is not applicable. This device is an examination glove and does not involve any algorithm or AI for standalone performance.

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

• The ground truth for this device's performance is based on objective measurements against established performance standards and chemical permeation resistance thresholds.
  • For physical properties (length, thickness, tensile strength, elongation, watertightness, powder content): The ground truth is the quantitative measurement compared against the specified ASTM standard values.
  • For chemical permeation (chemotherapy drugs, Fentanyl Citrate): The ground truth is the experimentally determined Minimum Breakthrough Detection Time (BDT) in minutes, measured according to ASTM D6978-05(2019).
  • For biocompatibility (irritation, sensitization, cytotoxicity, acute systemic toxicity): The ground truth is the experimental findings and conclusions derived from tests conducted under ISO 10993 series standards.

8. The sample size for the training set:

• This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the context of AI/ML.

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

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

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