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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.

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.

The provided document describes the acceptance criteria and a study that proves a medical device, specifically "Powder Free Nitrile Examination Gloves," meets those criteria. 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 Data Provenance

The document does not specify the exact sample size used for each test. However, it indicates that the tests conform to ASTM standards (D6319, D5151, D6124, F720) and 16CFR Part 1500, which inherently define the sample sizes and methodologies for these tests.

• Data Provenance: The tests are conducted by the manufacturer, IDEAL QUALITY SDN. BHD., located in Malaysia. The type of study (retrospective or prospective) is not explicitly stated, but given the nature of product testing for regulatory clearance, it would be prospective testing conducted by the manufacturer.

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

This document describes the testing of a medical glove, which relies on objective, standardized physical, chemical, and biological tests rather than subjective human interpretation of images or symptoms. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic AI is not applicable here. The "ground truth" is established by the defined test methods themselves and the laboratories performing these tests.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective and based on established industry standards and regulations. There is no mention of an adjudication process among human readers or experts for the results of these physical and biological tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret cases, and the AI's impact on their performance is measured. For a physical device like an examination glove, this is not applicable.

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

This question is not applicable to the device described. The device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used is based on objective, standardized test methods and criteria defined by:

• ASTM International standards (e.g., D6319, D5151, D6124, F720)
• U.S. Code of Federal Regulations (e.g., 16CFR Part 1500 for skin irritation).

These standards dictate the acceptable limits for various physical properties, freedom from defects, and biocompatibility, which constitute the "ground truth" for the device's performance.

8. The Sample Size for the Training Set

This question is not applicable. The device is a manufacturing product (gloves) and does not involve AI or machine learning models that require a "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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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 Latex Examination Gloves Polymer Coated with Protein Content Labeling Claim (100 Micrograms or Less)

This document is a 510(k) premarket notification approval letter from the FDA for "Powder-Free Latex Examination Gloves Polymer Trade Name: Coated with Protein Content Labeling Claim (100 Micrograms or Less)."

It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance, but does not include any performance data, study designs, or ground truth information relevant to the original request.

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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.

Latex Examination Gloves, Powdered

Here's a breakdown of the requested information based on the provided FDA 510(k) clearance letter for "Latex Examination Gloves, Powdered":

Important Note: The provided document is an FDA clearance letter, which means the device has already gone through the review process. This letter approves the device based on a previous submission that contained the details of the studies and acceptance criteria. Therefore, the letter itself does not explicitly list the acceptance criteria or the full study details, but rather confirms that the device has met the requirements for substantial equivalence.

To fully answer your request, one would typically need to refer to the original 510(k) submission (K974660). However, based on the nature of this particular device (Latex Examination Gloves), we can infer common acceptance criteria and the type of studies usually conducted for such products.

Inferred Acceptance Criteria and Reported Device Performance (based on common standards for examination gloves):

Explanation:
For medical examination gloves, the primary performance characteristics revolve around their physical strength, barrier integrity (preventing fluid/pathogen transfer), and biocompatibility (not causing adverse reactions on the skin). The FDA's 510(k) clearance implies that the device has demonstrated substantial equivalence to a predicate device, which inherently means it has met these types of performance standards.

1. A table of acceptance criteria and the reported device performance:
See table above. The "reported device performance" is implied by the FDA's "substantial equivalence" finding. The actual numbers would be in the original K974660 submission.

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

• Sample Size: Not specified in the clearance letter. For barrier integrity (Freedom from Holes), AQL (Acceptable Quality Limit) sampling plans are typically used (e.g., ANSI/ASQ Z1.4 for attributes sampling), which dictate sample sizes based on lot size and desired AQL level. For physical properties, standard test methods (e.g., ASTM D412) specify sample numbers (e.g., 5-10 specimens per test). Biocompatibility tests usually involve a small number of animal subjects (e.g., 3-5 for irritation/sensitization).
• Data Provenance: Not specified in the clearance letter. Typically, device manufacturers conduct these tests in their own labs or through accredited contract testing organizations. The country of origin of the data would likely be Malaysia (where Ideal Quality Sdn. Bhd. is located) or another country with accredited testing facilities.
• Retrospective or Prospective: These types of performance and safety tests are prospective studies performed specifically to demonstrate compliance with standards for the 510(k) submission.

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 question is more applicable to diagnostic devices involving image interpretation or complex clinical assessments. For a physical device like examination gloves:

• Ground Truth Establishment: The "ground truth" for gloves is established by objective, standardized test methods designed to measure physical properties (e.g., ISO, ASTM standards). There isn't an "expert" consensus in the same way as in diagnostic AI.
• Experts involved: The "experts" would be the laboratory personnel performing the standardized tests, who are qualified and trained in operating the testing equipment and interpreting results according to the specified standards (e.g., trained technicians, chemists, materials scientists). Their qualifications would include proficiency in the specific ASTM or ISO test methods.

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

• Adjudication method: Not applicable in the sense of expert consensus for diagnostic tasks. The results of the physical and chemical tests are objective measurements. Any "adjudication" would refer to internal lab quality control processes, where results might be cross-checked or equipment calibrated.

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:

• MRMC Study: Not applicable. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). Examination gloves are physical barrier devices, not diagnostic tools.

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

• Standalone Performance: Not applicable. This concept applies to AI algorithms. Examination gloves do not have an "algorithm" component. Their "performance" is inherently standalone in the sense that their physical characteristics are tested directly.

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

• Type of Ground Truth: For examination gloves, the "ground truth" is derived from:
  • Standardized Test Methods: Adherence to established international and national standards (e.g., ASTM D3578 for medical examination gloves, ISO 11193 for single-use medical examination gloves) which define acceptable limits for tensile strength, elongation, freedom from holes, etc.
  • Reference Materials/Controls: Use of calibrated equipment and reference materials to ensure accurate measurements.
  • Chemical Analysis: For biocompatibility and powder content.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This concept applies to machine learning models that require a 'training set' to learn patterns. Examination gloves are manufactured physical products and do not involve a training set in this context. Their design and manufacturing processes are based on engineering principles and material science, not AI training.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for physical medical devices like examination gloves. The "ground truth" for ensuring quality and safety in manufacturing is established through adherence to Good Manufacturing Practices (GMP) and ongoing quality control testing against established product specifications.

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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 Patient Examination Glove

I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for "Powder-Free Latex Examination Gloves" and an "Indications For Use" statement.

This document does not include any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how ground truth was established for it.

The document is solely a clearance letter stating that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls. It does not delve into the specific performance metrics or studies you are asking for.

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