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Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner

The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.

The document describes the Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile, manufactured by PT Mandiri Inti Buana. The device is a disposable glove intended for medical purposes to prevent contamination between patient and examiner.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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 explicitly state the sample sizes used for each specific test (e.g., for dimension, pinholes, etc.). It only indicates that the device "Meets" the specified standards.

• Data Provenance: The manufacturing company is PT Mandiri Inti Buana, located in Tanjung Morawa, SUMUT - INDONESIA. It is implied that the testing was conducted by or for this manufacturer, although the specific testing location is not mentioned. The document does not specify whether the data is retrospective or prospective.

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 is not applicable as the device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert consensus on diagnostic images or clinical outcomes. The "ground truth" is established by the defined ASTM and FDA test methods and their acceptance criteria.

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

Not applicable. The performance is determined by direct measurement against quantitative and qualitative standards using defined test methods, not by expert adjudication of subjective assessments.

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-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This device is a physical product (medical glove), 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 based on established industry standards and regulatory requirements:

• ASTM standard D 3578-01 ae²: This is a standard specification for rubber examination gloves.
• FDA 21 CFR 800.20 (for Freedom from Pinholes) and FDA 1000 ml Water Leak Test: These are regulatory requirements for pinhole detection in medical gloves.
• D6124 - 01: Standard test method for residual powder on medical gloves.
• D 5712 - 99: Standard test method for analysis of protein in natural rubber latex products.
• Primary Skin Irritation in Rabbits and Dermal Sensitization tests: These are standard biological evaluation tests to assess biocompatibility.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."

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

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

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POWDER TREE NITRILE EXAMINATION GLOVES, BLUE NON STERILE is a disposable device and make of Synthetic Is a Gropodosatibits rubber like Characteristics Intended For Medical Purpose that is worn on the Incended roz finger to prevent contamination between patient and examiner -

The Powder Free Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test.

The provided document describes the acceptance criteria and performance data for "Powder Free Nitrile Blue Examination Gloves, Blue, Non Sterile." This is a medical device and not an AI/ML powered device, so many of the requested fields are not applicable.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a numerical sample size for the various tests. It mentions "Testing, and Device Test Report of Compliance of finished gloves are provided in Attachment D, E and F" which would presumably contain this information, but these attachments are not included in the provided text.
• Data Provenance: The tests were conducted by PT Mandiri Inti Buana, a manufacturer located in SUMUT – INDONESIA. The data appears to be prospective as it is part of a premarket notification for a new device.

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 physical product (examination gloves), and its performance data is based on standardized physical and chemical tests, not expert interpretation of outputs.

4. Adjudication method for the test set:

Not applicable for this type of device. Performance is objectively measured against 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-powered diagnostic tool.

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

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used:

The ground truth used for this device is based on established ASTM (American Society for Testing and Materials) standards (specifically D 6319-00aE3 and D 6124-01) and FDA requirements (specifically the 1000 ml Water Leak Test and 21 CFR 800.20 for freedom from pinholes). These are objective, internationally recognized performance specifications for examination gloves.

8. The sample size for the training set:

Not applicable, as this is a physical product and not a machine learning model.

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

Not applicable, as this is a physical product and not a machine learning model.

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Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 and FDA 1000 ml Water Leak Test.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PT. Mandiri Inti Buana examination gloves:

Overview:

This submission describes a Class I medical device (Powder Free Latex Examination Gloves, Non-Sterile) and seeks a 510(k) clearance based on substantial equivalence to legally marketed predicate devices. The "study" here refers to non-clinical performance testing conducted to demonstrate compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on the "Study" and Performance Data:

The document describes non-clinical performance testing that demonstrates the device meets the specified ASTM standards and FDA requirements. This is not a "study" in the traditional sense of a clinical trial or a comparative effectiveness study involving human subjects or experts, but rather a series of laboratory tests.

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

• Sample Size: The document does not specify the exact sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many rabbits for biocompatibility). It simply states that the device "Meets" the standards or provides a quantitative result (e.g., "< 2 mg/glove"). The sample sizes would be dictated by the specific ASTM and FDA test methods referenced (e.g., D 3578-01ae2, D 6124-01, D 5712-99, and FDA 21 CFR 800.20).
• Data Provenance: The document does not explicitly state the country of origin for the test data itself. The manufacturer is located in Indonesia. The testing would have been conducted in a laboratory, but the location of that lab is not specified. The data is retrospective in the sense that the tests were performed and analyzed before the 510(k) submission.

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

• Experts: Not applicable in the context of this device. The "ground truth" for these tests are the objective measurements and pass/fail criteria defined by the ASTM standards and FDA regulations themselves.
• Qualifications: The individuals performing the tests would be qualified lab technicians, but their specific number and qualifications are not mentioned as they are performing established, standardized tests, not making subjective expert judgments like in image analysis or diagnostic studies.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests are objective measurements against established standards. There is no subjective interpretation requiring an adjudication process. Results are either "Meets" or they don't, or they fall within a specified quantitative range.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers (e.g., radiologists) interpret cases and their performance (with and without AI assistance) is compared. These gloves are a Class I barrier device, not a diagnostic tool requiring human interpretation.

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

• Standalone Performance: Not applicable. This device does not involve an algorithm or AI. Its performance is assessed through physical, chemical, and biological laboratory tests, not automated analysis.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device is based on established and objective physical, chemical, and biological standards. Specifically:
  • ASTM standards (e.g., D 3578-01ae2 for dimensions, physical properties, freedom from pinholes; D 6124-01 for powder residue; D 5712-99 for water soluble protein content).
  • FDA regulations (e.g., 21 CFR 800.20 for the 1000 ml Water Leak Test for pinholes).
  • Biocompatibility test methods (Primary Skin Irritation in Rabbits, Dermal Sensitization), which have established protocols and endpoints for determining "Pass" or "Fail."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the context of algorithm development.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set.

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Latex Examination Gloves, Powdered, Non-Sterile is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The Latex Examination Gloves, Powdered, Non Sterile meets all the reguirements of ASTM standard D 3578 - 01a22 and FDA 1000 ml Water Leak Tost.

This document describes the acceptance criteria and performance of the PT. Mandiri Inti Buana Latex Examination Gloves, Powdered, Non-Sterile.

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 the test set for each of the performance characteristics. The tests likely fall under quality control or material testing conducted by the manufacturer.
• Data provenance: The testing was performed by PT. Mandiri Inti Buana, an Indonesian company. The data is retrospective in the context of this 510(k) submission, as it represents pre-market testing results.

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. The characteristics being tested are objective physical and chemical properties of a medical device (gloves), not diagnostic interpretations requiring expert consensus. The "ground truth" is established by adherence to recognized ASTM and FDA standards.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective interpretations (e.g., medical image reading) where multiple experts might disagree. Here, the tests are objective measurements against defined 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. The device is a physical medical device (examination gloves), not an AI-powered diagnostic tool, and therefore MRMC studies for AI assistance are not relevant.

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

• This information is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The ground truth for the device's performance is based on established industry standards and regulatory requirements. Specifically, ASTM International standards (D 3578 - 01a2, D 6124 - 01) and FDA regulations (21 CFR 800.20 for water leak test). For biocompatibility, the ground truth is established by standard biological testing protocols (Primary Skin Irritation in Rabbits and Dermal Sensitization assays) designed to demonstrate safety.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of testing a physical medical device like examination gloves. The manufacturing process is subject to quality control, but not in the same way an AI algorithm is "trained."

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

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

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