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A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 (2019), Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Test Chemotherapy Drugs are as follows: Carmustine 3.3mg/ml, Cisplatin 1 mg/ml, Cyclophosphamide 20 mg/ml, Dacarbazine 10 mg/ml, Doxorubicin, HCl 2 mg/ml, Etoposide 20 mg/ml, Fluorouracil 50 mg/ml, Methotrexate 25 mg/ml, Mitomycin 0.5 mg/ml, Oxaliplatin 5 mg/ml, Paclitaxel 6 mg/ml, Thiotepa 10 mg/ml, Vincristine 1 mg/ml. Test Fentanyl Citrate are as follows: Fentanyl Citrate Injection 100mcg/2ml. Warning: Do not use with Carmustine and Thiotepa. Please note that the following drugs have low permeation times: (1)Carmustine - 14.1 minutes (2)Thiotepa - 57.2 minutes.

Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate meets all the requirements of ASTM standards D6319-19, D6978-05 (2019) and FDA 21 CFR 880.6250. Nitrile Powder Free Blue Patient Examination Gloves Non-sterile, Tested For Use With Chemotherapy Drugs are Class I patient examination gloves bear the product code Nitrile - LZA, LZC, OPJ and QDO (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. These gloves are blue in color and are powder free. The gloves are ambidextrous i.e., can be worn on right hand or left hand, single use disposable devices that come in five sizes (XS, S, M, L and XL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

The provided document is a 510(k) summary for Nitrile Powder Free Blue Patient Examination Gloves. It details non-clinical testing to demonstrate the device meets acceptance criteria. No information regarding clinical effectiveness studies (such as MRMC studies or standalone algorithm performance for AI devices) is present, as this is not an AI/ML device.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for holes, number of material samples for tensile strength). However, the tests are conducted in accordance with the specified ASTM and ISO standards, which typically include defined sampling plans.

• Data Provenance: The origin of the data is from non-clinical laboratory testing performed by "Mah Sing Healthcare Sdn Bhd" or their contracted laboratories, as part of the 510(k) submission process. The submission is from Malaysia. This is prospective data generated for regulatory submission.

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

This information is not applicable as the device is a physical medical glove and the testing involves objective measurement against pre-defined physical, chemical, and biological standards, not interpretation by human experts or AI algorithms. Ground truth is established by the test procedures and acceptance criteria defined in the ASTM and ISO standards.

4. Adjudication Method for the Test Set:

This is not applicable. As stated above, the device performance is evaluated against objective standards, not through adjudication of expert interpretations.

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. The device is a physical medical glove. The submission does not involve Artificial Intelligence (AI) or Machine Learning (ML) components, nor does it relate to diagnostic image interpretation where MRMC studies would typically be conducted.

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

This is not applicable. The device is a physical medical glove and does not involve an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on defined performance specifications and measurement methodologies established by widely recognized consensus standards such as ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example:

• Physical dimensions: Measured against specified millimeter ranges.
• Tensile strength and elongation: Measured against minimum MPa and percentage values.
• Freedom from holes: Assessed against an Acceptable Quality Limit (AQL) per ASTM D5151-19.
• Chemotherapy drug permeation: Measured as breakthrough detection time in minutes per ASTM D6978-05.
• Biocompatibility: Assessed based on observable reactions in animal models according to ISO 10993 series and reported as "Passed" or "Not an irritant/sensitizer/systemic toxin."

8. The Sample Size for the Training Set:

This is not applicable. There is no "training set" as this device is not an AI/ML product. The manufacturing process is controlled and monitored, but there isn't a data-driven training phase for the device itself.

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

This is not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for one. The "ground truth" for glove manufacturing is established through quality control and adherence to standardized manufacturing practices and raw material specifications.

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

Nitrile Powder Free Blue Examination Gloves, Non-Sterile are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).

The gloves are made from acrylonitrile-butadiene copolymer dispersion. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface.

These gloves are blue in color and are powder free. The gloves are ambidextrous single use disposable devices that come in six sizes (XS, S, M, L, XL and XXL). The physical properties of glove, i.e., tensile strength meet ASTM D 6319-19.

The document describes the acceptance criteria and the results of non-clinical testing for the Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile (K221378).

Here's a breakdown of the requested 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 explicitly state the exact sample sizes used for each specific non-clinical test. However, it implicitly indicates that various sizes of gloves (XS, S, M, L, XL, XXL) were tested for several parameters (e.g., residual powder, length, width, thickness, tensile strength, ultimate elongation), meaning multiple samples were drawn for each size.

• Data Provenance: The tests were performed by Tec Gloves Industry (M) Sdn. Bhd. for their "Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile". This suggests the data provenance is from the manufacturer's internal testing. The country of origin of the manufacturer is Malaysia. The data is prospective as it was generated to demonstrate compliance for this specific device.

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

Not applicable. The tests performed are non-clinical, objective measurements based on specified ASTM and ISO standards, not subjective expert evaluation of medical images or conditions.

4. Adjudication Method for the Test Set

Not applicable. This is not a human-in-the-loop study requiring adjudication of expert opinions. The performance criteria are defined by established international standards (ASTM, ISO).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a 510(k) submission for patient examination gloves, which are physical medical devices, not an AI/software device that would involve human readers or cases.

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

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

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on predefined acceptance criteria specified by international standards (ASTM D6124-06, ASTM D5151-19, ASTM D6319-19, ISO 10993-10, ISO 10993-11). The results are quantitative measurements or qualitative observations (e.g., "not an irritant") against these established standard requirements. For example, for "Residual Powder Content," the ground truth is "Less than 2mg/glove."

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no concept of 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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