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The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine ( 3.3mg/mL 3,300 ppm) 11.1 min Cisplatin ( 1.0 mg/mL 1,000 ppm) >240 min Cyclophosphamide (20 mg/mL 20,000 ppm) >240 min Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) >240 min Dacarbazine (10 mg/mL 10,000 ppm) >240 min Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm) >240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min Methotrexate (25.0 mg/mL 25,000 ppm) >240 min Mitomycin C (0.5 mg/mL 500 ppm) >240 min Mitoxantrone HCL (2.0 mg/mL 2,000 ppm >240 min Paclitaxel (6.0 mg/mL 6,000 ppm) >240 min Thiotepa (10.0 mg/mL 10.000 ppm) 34.8 min Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min Fentanyl Citrate Injection (100 mcg/2mL) >240 min Note: Carmustine and Thiotepa have extremely low permeation times of 11.1 and 34.8 minutes respectively. Warning: Do Not Use with Carmustine. Thiotepa

The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in five sizes, extra small, small, medium, large, and extra-large, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.

The provided document describes the acceptance criteria and results for the "Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl" device.

Here's an analysis of the requested information:

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

Note on Biocompatibility: The document states that despite the in vitro cytotoxicity showing "potential toxicity," the overall biocompatibility assessment was deemed acceptable, asserting it "does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment."

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

The document does not specify the exact sample sizes used for each performance test (e.g., how many gloves were tested for dimensions, holes, tensile strength, or chemotherapy permeation). It references standards like ASTM D6319-19, ASTM D5151-19 (G-1, AQL 2.5), ASTM D6124-06, and ASTM D6978-05, which would prescribe the methodology and sample sizes.

The data provenance regarding country of origin or retrospective/prospective nature is not explicitly mentioned. The applicant, Anhui Powerguard Technology Co., Ltd., is based in China, suggesting the testing may have been conducted there or through contract labs globally.

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 device is a physical medical device (examination gloves), not an AI/software device that requires expert interpretation of images or data to establish ground truth. Therefore, the concept of "experts used to establish ground truth" in the context of medical imaging or AI algorithms is not applicable here. The "ground truth" for this device is established by physical and chemical testing against established engineering and safety standards.

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

Similarly, as this is a physical device and not an AI/software for diagnostic interpretation, adjudication methods like 2+1 or 3+1 are not applicable. Performance is measured against quantitative criteria defined by international 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools, not for medical gloves.

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

No, this question is not applicable. The device is a physical product (gloves), not an algorithm.

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

The "ground truth" for the device's performance is established by:

• International Standards: ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).
• Biocompatibility Standards: ISO 10993-1, ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Dermal Sensitization), ISO 10993-11 (Acute Systemic Toxicity), and ISO 10993-23 (Primary Skin Irritation).

These standards define the methodologies and acceptance limits for evaluating the physical, chemical, and biological properties of the gloves.

Regarding In Vitro Cytotoxicity: The report notes that the "test article extract showed potential toxicity." However, the analysis in the 510(K) Summary explicitly states: "Analysis: In vitro cytotoxicity and acute systemic toxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment." This indicates that while an in vitro test showed some indication, the overall biocompatibility assessment, likely considering other in vivo tests like skin irritation and sensitization which passed, led to the conclusion of acceptable biocompatibility. This implicitly uses the wider expert consensus and risk assessment methodology embedded in the ISO 10993 series of standards as the 'ground truth' for biocompatibility.

8. The sample size for the training set

This question is not applicable as this is a physical medical device, not an AI/software device that requires a training set.

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

This question is not applicable as this is a physical medical device, not an AI/software device.

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A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the hand or finger to prevent contamination between examiner and patient.

Powder Free Nitrile Examination Glove, Non-sterile (Blue)

This document is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about an AI/ML medical device, acceptance criteria, or performance study data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The information requested (e.g., sample sizes, expert qualifications, ground truth, MRMC studies) is relevant to the evaluation of AI/ML devices, not to a simple medical device like examination gloves.

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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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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.

AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitrile - LZA (2 ICFR880.6250). AMADEX - Nitrile Powder Free Examnation Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is single-use device to prevent contamination between patient and examiner.

This document describes the acceptance criteria and study results for the AMADEX Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

The provided document is a 510(k) premarket notification for Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue). This is a medical device of Class I and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI/ML algorithm.

Therefore, the requested information about AI model acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets is not applicable to this document.

The document describes the acceptance criteria and device performance as they relate to the physical and biocompatibility characteristics of the examination gloves. Here's a summary based on the provided text:

1. Acceptance Criteria and Reported Device Performance for Powder Free Nitrile Patient Examination Gloves

The acceptance criteria for these medical gloves are primarily based on established ASTM (American Society for Testing and Materials) and ISO standards. The reported device performance is compared against these standards and the predicate device.

Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for Testing and Data Provenance

The sample sizes for testing are defined by the specific ASTM standards followed.

• Physical Properties (Tensile Strength, Elongation): Not explicitly stated, but typically these tests involve a specified number of specimens per batch or test run according to ASTM D412.
• Watertight (Hole Detection): Sample size of 315 pieces for a batch sampling of 150,001 to 500,000 gloves, based on Inspection Level GI and AQL 1.5. This is a prospective test conducted on manufactured gloves.
• Powder Free (Residual Powder): Sample size of 5 pieces.
• Biocompatibility Tests (Skin Irritation, Sensitization, Cytotoxicity, Systemic Toxicity): These tests are typically conducted on animal models (e.g., mice, rabbits) and cell cultures. The counts of animals (e.g., number of test group animals vs. control group animals) are not explicitly stated in this summary, but the results (e.g., "no mortality," "no erythema") indicate biological testing. This data would be prospective from laboratory testing.
• Data Provenance: The manufacturing company is Meditech Gloves Sdn Bhd, Malaysia. The tests described are laboratory and quality control tests conducted as part of the manufacturing and regulatory submission process.

3. Number of Experts and Qualifications for Ground Truth

This type of medical device submission (examination gloves) does not involve human expert interpretation of images or complex diagnostic data like an AI/ML device would. Therefore, there are no "experts establishing ground truth" in the diagnostic sense. The "ground truth" for the performance of these gloves is defined by the objective, quantifiable results of the standardized physical and biocompatibility tests (e.g., direct measurements of tensile strength, elongation, amount of powder, number of leaks, observed biological reactions in laboratory tests).

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The tests are objective and quantitative.

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

Not applicable. This is not an AI/ML diagnostic device that interacts with human readers or interprets medical cases.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical examination glove, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for this device is based on objective, quantitative measurements and laboratory test results against established international standards (ASTM, ISO) for material properties, physical dimensions, leak detection, and biocompatibility.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm 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 an AI/ML algorithm, the concept of establishing ground truth for it does not apply here.

In summary, the provided document is a regulatory submission for a physical medical device (examination gloves) where "acceptance criteria" relate to meeting specific physical and biological performance standards, not to the performance of an AI/ML algorithm.

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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.

Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a563 Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from BarrierPro™ synthetic copolymer rubber latex, a polybutadiene based copolymer. They are blue in colour and are powder free.

The provided document describes the acceptance criteria and performance of Non-Sterile Blue & White Colour Powder Free Barrier Pro™ Polybutadiene Copolymer Examination Gloves. This device is a medical glove, not an AI/ML powered medical device, and therefore the acceptance criteria and study detailed below are for the physical and chemical properties of the gloves, not an algorithm's performance.

Here's the information based on the provided text, formatted to your request where applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

In addition, the device successfully passed the Bio-compatibility Test, which included a Primary Dermal Irritation Test and a Guinea Pig Sensitization (Buehler) test.

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 sample size used for the test set for each of the physical property tests. The data provenance is also not specified beyond the fact that the manufacturer is YTY Industry (Manjung) Sdn Bhd (Malaysia). There is no indication whether the testing was retrospective or prospective.

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

This question is not applicable as the "ground truth" here refers to objective physical and chemical properties measured according to established ASTM standards, not subjective interpretations by human experts.

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

This question is not applicable as the testing involves objective measurements against predefined standards (ASTM D6319-00a3 and FDA watertight test for physical properties, and bio-compatibility tests) and does not involve human adjudication for "ground truth".

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 question is not applicable as the device is a medical glove, not an AI/ML powered medical device.

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

This question is not applicable as the device is a medical glove, not an AI/ML powered medical device.

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

The "ground truth" in this context is based on established industry standards and objective measurements. Specifically:

• ASTM D6319-00a3 Standard Specification for Nitrile Examination Gloves for Medical Application for physical properties (e.g., length, width, thickness, tensile strength, elongation).
• FDA 1000ML watertight test for barrier integrity.
• Bio-compatibility tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) for biological safety.

8. The sample size for the training set

This question is not applicable as the device is a medical glove, not an AI/ML powered medical device that requires a training set.

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

This question is not applicable as the device is a medical glove, not an AI/ML powered medical device that requires a training set.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device