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

Green Non Sterile Powder Free Nitrile Examination Gloves

The provided text is a 510(k) clearance letter from the FDA for "Green Non Sterile Powder Free Nitrile Examination Gloves." This document is a regulatory communication for a medical device and does not contain information regarding an AI/ML medical device, clinical study results, or performance criteria as would be relevant for devices that use algorithms or sophisticated analytical methods.

Therefore, I cannot extract the requested information (acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) because this information is not present in the provided FDA clearance letter for examination gloves.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls, but it does not detail performance studies or criteria relevant to AI/ML devices.

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Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentaryl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

The following drugs and concentrations have been tested the minimum breakthrough result of >240 minutes: Arsenic Trioxide 1.0 Azacitidine (Vidaza) 25.0 Bendamustine HCl 5.0 Bleomycin Sulfate 15.0 Busulfan 6.0 Carboplatin 10.0 Carfilzomib 2.0 Cetuximab 2.0 Chloroquine 50.0 Cisplatin 1.0 Cladribine 1.0 Cyclophosphamide (Cytoxan) 20.0 Cyclosporin A 100.0 Cytarabine 100.0 Cytovene (Ganciclovir) 10.0 Dacarbazine 10.0 Daunorubicin 5.0 Decitibine 5.0 Docetaxel 10.0 Doxorubicin Hydrochloride 2.0 Epirubicin (Ellence) 2.0 Etoposide (Toposar) 20.0 Fludarabine 25.0 Fluorouracil 50.0 Fulvestrant 50.0 Gemcitabine (Gemzar) 38.0 Idarubicin 1.0 Ifosfamide 50.0 Irinotecan 20.0 Mechlorethamine HCl 1.0 Melphalan 5.0 Mesna 50.0 Methotrexate 25.0 Mitomycin C 0.5 Mitoxantrone 2.0 Oxaliplatin 2.0 Paclitaxel 6.0 Paraplatin 10.0 Pemetrexed 25.0 Pertuzumab 30.0 Propofol 10.0 Raltitrexed 0.5 Retrovir 10.0 Rituximab 10.0 Temsirolimus 25.0 Topotecan HCl 1.0 Trastuzumab 21.0 Triclosan 2.0 Trisenox (Arsenic Trioxide) 1.0 Velcade (Bortezomib) 1.0 Vinblastine 1.0 Vincristine Sulfate 1.0 Vinorelbine 10.0 Zoledronic Acid 0.8

The following drugs have permeation times lower than 240 minutes: Carnustine: 55.1 minutes and Thiotepa: 199.2 minutes.

Fentaryl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes.

Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentaryl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

This document is a 510(k) clearance letter for Blue Non Sterile Powder Free Nitrile Examination Gloves. It details the device's intended use and claims about its resistance to chemotherapy drugs, gastric acid, and fentanyl permeation. It does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/machine learning device.

The questions in the prompt are specific to the performance evaluation of an AI/machine learning-based medical device. This document describes the device performance claims for a physical medical device (gloves) based on physical permeation testing against various chemical agents, not an AI algorithm.

Therefore, I cannot provide answers to the requested information based on the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance: While drug permeation times are listed, these are performance metrics for a physical glove, not an AI device. There are no "acceptance criteria" in the AI sense (e.g., target precision, recall, AUC).
2. Sample size for test set and data provenance: Not applicable to a physical glove's chemical resistance testing.
3. Number of experts for ground truth and qualifications: Not applicable; ground truth for chemical resistance is determined by laboratory measurements, not expert consensus.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for human reader performance with/without AI assistance.
6. Standalone (algorithm only) performance: Not applicable; there is no algorithm.
7. Type of ground truth used: For these gloves, the "ground truth" is laboratory measurement of chemical permeation according to ASTM D6978-05.
8. Sample size for the training set: Not applicable; there's no training set for an AI algorithm.
9. How ground truth for the training set was established: Not applicable.

The document describes the testing methodology for the gloves' chemical resistance, which is analogous to how device performance is evaluated, but it's for a physical product, not an AI system. Specifically:

• Acceptance Criteria/Performance: The device "acceptably" resists permeation by various chemotherapy drugs, gastric acid, and fentanyl.
  • For most listed chemotherapy drugs, the minimum breakthrough result was ">240 minutes" when tested according to ASTM D6978-05.
  • For BCNU (Carmustine) and Thiotepa, permeation times were lower (55.1 minutes and 199.2 minutes, respectively).
  • For Fentanyl Citrate Injection and Gastric Acid, no breakthrough was detected up to 240 minutes.
• Study Proving Acceptance: The device was tested for use with chemotherapy drugs, gastric acid, and fentanyl permeation resistance claims using ASTM D6978-05. This standard dictates the testing methodology for assessing the resistance of medical gloves to permeation by chemotherapy drugs. The results obtained from this standard testing are what "prove" the device meets its claims.

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Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Tested for Use with Chemotherapy Drugs - Gloves have been tested for use with chemotherapy drugs using ASTM D6978-05 and will be labeled with a statement of compliance and a summary of the testing results.

Tested chemotherapy drugs and average breakthrough detection time (minutes) are as follows: Arsenic Trioxide 1.0 mg/ml >>240 mins
Azacitidine (Vidaza) 25.0 mg/ml > 240 mins Bendamustine HC1 5.0 mg/ml >>240 mins Bleomycin Sulfate 15.0 mg/ml >>240 mins Busulfan 6.0 mg/ml > 240 mins Carboplatin 10.0 mg/ml > 240 mins Carmustine (BCNU) 3.3 mg/ml 12.7 mins Carfilzomib 2.0 mg/ml > 240 mins Cetuximab 2.0 mg/ml >>240 mins Chloroquine 50.0 mg/ml >>240 mins Cisplatin 1.0 mg/ml > 240 mins Cladribine 1.0 mg/ml >>240 mins Cyclophosphamide (Cytoxan) 20.0 mg/ml > 240 mins Cyclosporin A 100.0 mg/ml >> 240 mins Cytarabine 100.0 mg/ml > 240 mins Cytovene (Ganciclovir) 10.0 mg/ml > 240 mins Dacarbazine 10.0 mg/ml > 240 mins Daunorubicin 5.0 mg/ml >>240 mins Decitibine 5.0 mg/ml >>240 mins Docetaxel 10.0 mg/ml >>240 mins Doxorubicin Hydrochloride 2.0 mg/ml >>240 mins Epirubicin (Ellence) 2.0 mg/ml >> 240 mins Etoposide (Toposar) 20.0 mg/ml >>240 mins Fludarabine 25.0 mg/ml >>240 mins Fluorouracil 50.0 mg/ml > 240 mins Fulvestrant 50.0 mg/ml > 240 mins Gemcitabine (Gemzar) 38.0 mg/ml >> 240 mins Idarubicin 1.0 mg/ml > 240 mins Ifosfamide 50.0 mg/ml >>240 mins Irinotecan 20.0 mg/ml >>240 mins Mechlorethamine HCl 1.0 mg/ml > 240 mins Melphalan 5.0 mg/ml >>240 mins Mesna 50.0 mg/ml >240 mins Methotrexate 25.0 mg/ml >>240 mins Mitomycin C 0.5 mg/ml >>240 mins
Mitoxantrone 2.0 mg/ml > 240 mins Oxaliplatin 2.0 mg/ml > 240 mins Paclitaxel 6.0 mg/ml >>240 mins Paraplatin 10.0 mg/ml >>240 mins Pemetrexed 25.0 mg/ml >>240 mins Pertuzumab 30.0 mg/ml >>240 mins Propofol 10.0 mg/ml > 240 mins Raltitrexed 0.5 mg/ml >>240 mins Retrovir 10.0 mg/ml > 240 mins Rituximab 10.0 mg/ml > 240 mins Temsirolimus 25.0 mg/ml >240 mins Thiotepa 10 mg/ml 35.8 mins Topotecan HCl 1.0 mg/ml > 240 mins Trastuzumab 21.0 mg/ml >240 mins Triclosan 2.0 mg/ml >>240 mins Trisenox (Arsenic Trioxide) 1.0 mg/ml >> 240 mins Velcade (Bortezomib) 1.0 mg/ml > 240 mins Vinblastine 1.0 mg/ml >>240 mins Vincristine Sulfate 1.0 mg/ml > 240 mins Vinorelbine 10.0 mg/ml >>240 mins Zoledronic Acid 0.8 mg/ml > 240 mins

CAUTION: Testing showed an average breakthrough time of 35.8 minutes with Thiotepa and 12.7 minutes with Carmustine.

WARNING: Do not use with Carmustine and Thiotepa.

Fentanyl Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2mL) was found to have no breakthrough detected up to 240 minutes. Gastric Acid Permeation Resistance Claim - Under the testing conditions of ASTM D6978-05, was found to have no breakthrough detected up to 240 minutes.

Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The provided document is a 510(k) premarket notification letter from the FDA for examination gloves. It does not describe an AI/ML powered medical device, nor does it contain information about acceptance criteria, study data, ground truth, or other aspects related to the evaluation of such devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from this document. The questions about AI/ML device performance, human readers, training/test sets, and ground truth are not applicable to the content provided.

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Non Sterile Powder Free Polyurethane Examination Glove (Blue and Black colors) is a disposable device intended for medical purposed that is worn on the examiner's hand to prevent contamination between patient and examiner.

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)

This document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria, device performance metrics, or study details (sample size, data provenance, ground truth establishment, MRMC studies, standalone performance, etc.) for a medical device that would typically involve such a study (e.g., an AI-powered diagnostic device or a complex therapeutic device).

The information provided is purely administrative for a Class I medical device (non-powdered patient examination glove), indicating FDA clearance based on substantial equivalence rather than a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested table and study details based on the provided text.

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Ask a specific question about this device

A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.

The Nitrile Exam Gloves, Powder Free, Black, Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-10.

The provided text is for a 510(k) premarket notification for "NITRILE EXAM GLOVES, POWDER FREE, BLACK". This document describes the characteristics and testing of a medical device (nitrile examination gloves), not an artificial intelligence (AI) or algorithm-based device. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert review, and training/test set sample sizes are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test. It states that "Testing performed per ASTM D 6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application and 21 CFR 800.20." These standards would dictate the sampling plans and methodologies.

• Data Provenance: The manufacturing company is Central Medicare Sdn. Bhd. located in Malaysia. Testing would have been conducted to demonstrate compliance with ASTM and CPSC standards, which are international and US-based, respectively. While not explicitly stated, testing would be prospective for the purpose of this submission.

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

Not applicable. This is a physical device, and the ground truth is established through standardized physical, chemical, and biological testing methods, not expert interpretation of data.

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

Not applicable. This is a physical device. Test results are 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

Not applicable. This device is not an AI or algorithm-based product.

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

Not applicable. This device is not an AI or algorithm-based product.

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

The ground truth for this device is based on:

• Standardized Measurement: Physical dimensions, tensile strength, elongation, and powder residue are measured against the specifications outlined in ASTM standards.
• Defined Thresholds: Freedom from pin-holes is assessed against AQL (Acceptable Quality Level) criteria.
• Biological Response Protocols: Biocompatibility (dermal sensitization and primary skin irritation) is determined by conducting standardized animal tests (guinea pigs and rabbits) and observing the biological response according to established protocols from ASTM and CPSC. The "ground truth" is the absence of irritation or sensitization as defined by these protocols.

8. The sample size for the training set

Not applicable. This device is not an AI or algorithm-based product, so there is no training set in that context.

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

Not applicable. This device is not an AI or algorithm-based product.

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A powder free Nitrile Examination glove is a disposable device made of synthetic material that is worn on the hand for medical purposes to prevent contamination between patient and examiner.

The Powder Free Nitrile Examination Glove White Colored Class I patient examination gloves, Nitrile-80 LZA, will meet all the current specification for ASTM D6319-00a (Reapproved 2005)

This document is a 510(k) summary for a medical device called "POWDER FREE NITRILE EXAMINATION GLOVE WHITE COLORED." It outlines the device's characteristics, intended use, and its substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information, structured around your questions, though it's important to note that many of your specific questions about study design (like sample sizes, expert qualifications, adjudication methods, MRMC studies, training set details) are not applicable to this type of device submission. This is a submission for a Class I medical device (patient examination glove), which typically relies on established performance standards rather than complex clinical studies or AI algorithm evaluations.

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

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

• Sample Size: The document does not specify exact sample sizes for each test. For standards like ASTM D 6319-00a, ASTM D 5151-06, etc., the standards themselves define the sampling plans (e.g., AQL levels for pinholes) and test methodologies. Without access to the actual test reports, specific sample sizes cannot be determined from this summary.
• Data Provenance: Not explicitly stated, but the submitter is Central Medicare Sdn. Bhd. located in Malaysia. It is implied that the testing was conducted to meet international and US standards. The biocompatibility tests mention ISO 10993-10:2007 (E) and Consumer Product Safety Commission guidelines, which are international and US standards, respectively.
• Retrospective or Prospective: These tests are laboratory-based performance and biocompatibility assessments, conducted prospectively for the purpose of this submission to demonstrate compliance with standards.

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)

• Not Applicable. For a patient examination glove, "ground truth" as you might define it for an AI or diagnostic device does not apply. Performance is assessed against defined physical, chemical, and biological standards through laboratory testing, not expert interpretation of complex data.

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

• Not Applicable. Adjudication methods are not relevant for the type of objective laboratory tests conducted for this device. The tests have clear pass/fail criteria based on the specified 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

• Not Applicable. This device is a physical medical glove, not an AI or diagnostic imaging system. No MRMC study was performed.

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

• Not Applicable. This device has no algorithmic component.

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

• Objective Standards and Laboratory Results: The "ground truth" for this device's performance is defined by the objective pass/fail criteria established within recognized international and US standards (ASTM D 6319-00a, ASTM D 412-98, ASTM D 5151-06, ASTM D 6124-06, ISO 10993-10, CPSC guidelines) and the reproducible results obtained from laboratory testing against these standards.
• For biocompatibility, the "ground truth" is the absence of dermal sensitization or primary skin irritation based on standardized animal models.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI or machine learning device. The product development process involves design, manufacturing, and testing according to established engineering and quality control principles.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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

Blue Nitrile Examination Gloves, Powder Free

The provided document refers to a 510(k) premarket notification for Blue Nitrile Examination Gloves, Powder Free, and does not contain information about acceptance criteria or a study proving that a device (in the context of AI/software) meets acceptance criteria. The document is an FDA letter granting substantial equivalence for medical gloves, and the "Indication for Use" section simply states the intended purpose of the gloves.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study from this document. The questions you've posed (sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training) are all relevant to the evaluation of AI/software medical devices, but not to the type of device discussed in this document.

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