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A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.

Midas TouchTM - Nitrile Examination Gloves - Powder free, Green

This is a 510(k) premarket notification for "Midas Touch 191 - Nitrile Examination Gloves - Powder Free. Green." This document does not describe a study that proves the device meets specific acceptance criteria in the manner that a medical imaging AI or diagnostic device would. Instead, it is an FDA clearance letter based on substantial equivalence to a predicate device.

Therefore, many of the requested items (sample sizes, expert qualifications, MRMC studies, standalone performance, training data, etc.) are not applicable to this type of regulatory submission.

However, I can extract the relevant information regarding the device and its indications for use.

Here's a breakdown of the available information:

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

For examination gloves, the "acceptance criteria" are typically defined by recognized consensus standards, which include physical properties and barrier integrity. The FDA letter indicates that the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the relevant performance standards for patient examination gloves. However, the specific performance data against these standards are not included in this clearance letter. This letter is the outcome of the review, not the detailed submission itself.

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

• Not Applicable. This is not a study involving a test set of data in the context of an AI or diagnostic device. The clearance is based on demonstrating substantial equivalence to a predicate device, which typically involves testing the physical properties of the glove according to recognized standards. The sample sizes for these physical tests would be defined by the specific test methods (e.g., ASTM standards) but are not detailed in this clearance letter.

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. As above, there is no "ground truth" establishment in the context of image interpretation or diagnosis for this type of device. The quality and performance of the gloves are assessed through standardized physical and chemical tests, not expert consensus on medical images.

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

• Not Applicable.

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 an examination glove, not an AI or diagnostic tool that assists human readers.

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

• Not Applicable.

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

• The "ground truth" for examination gloves typically refers to the objective measurements of their physical and barrier properties against established, internationally recognized standards (e.g., ASTM D6319 for Nitrile Examination Gloves). These standards define acceptable performance ranges for attributes like tensile strength, elongation, and freedom from holes.

8. The sample size for the training set

• Not Applicable. This is not an AI or machine learning device; therefore, there is no training set.

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

• Not Applicable.

Summary of Device and Indication for Use:

• Device Name: Midas Touch™ - Nitrile Examination Gloves - Powder free, Green
• Manufacturer: Industrial Clothings Ltd., Prime Polymers Division
• 510(k) Number: K130846
• Indications for Use: "A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large."
• Regulatory Class: I
• Product Code: LZA (Patient Examination Glove)

This clearance indicates that the FDA has determined the device is "substantially equivalent" to currently marketed devices and can be legally marketed, based on fulfilling the general controls provisions of the Act and likely meeting relevant consensus standards. The detailed engineering and performance data are part of the original 510(k) submission, which is not fully included here.

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A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.

Not Found

The provided text is a 510(k) premarket notification for "Midas Touch™ Nitrile Examination Gloves - Powder-Free, Orange." This document is a regulatory submission for a medical device and does not contain information about a study proving the device meets acceptance criteria in the format typically found for AI/ML-based medical devices.

Instead, this document focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for lower-risk medical devices like gloves. It confirms that the device is intended for medical purposes, to be worn on the hand or finger to prevent contamination between patient and examiner.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details as they would apply to an AI/ML device, as this document pertains to a physical medical device (gloves).

Here's why the requested information categories are not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). For gloves, performance criteria would typically involve barrier integrity (e.g., AQL for pinholes), tensile strength, elongation, etc., which are not detailed here beyond the general claim of being "powder-free" and available in sizes.
2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of data in the context of an AI/ML algorithm.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth, in the AI/ML sense, is not established for gloves.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which doesn't apply to examination gloves.
6. Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There's no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory approval for examination gloves and does not contain the kind of study data requested for AI/ML device performance.

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A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.

Not Found

This document describes the 510(k) premarket notification for "Midas Touch™ - Nitrile Examination Gloves - Powder Free, Grey." The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the format typically seen for complex medical devices with quantitative diagnostic or performance metrics (e.g., sensitivity, specificity, accuracy).

However, for patient examination gloves, the primary acceptance criteria revolve around meeting established ASTM standards for physical properties and barrier integrity. The "Premarket Notification (510k) Summary" (which is typically part of an FDA submission but not fully contained in the provided letter and Indications for Use) would detail these.

Based on the context of FDA substantial equivalence for examination gloves, the implied acceptance criteria are that the Midas Touch™ gloves meet the relevant ASTM standards. The "study that proves the device meets the acceptance criteria" would be the testing conducted by the manufacturer according to these standards.

Here's a hypothetical table based on typical glove testing for a 510(k) submission, as these are the "performance" aspects a glove device would need to demonstrate:

Note: The specific ASTM standards and target values would be detailed in the applicant's 510(k) submission. This table is illustrative of the types of criteria and performance typically required for examination gloves.

The "Study That Proves the Device Meets the Acceptance Criteria":

The "study" confirming the device meets the acceptance criteria would be a series of bench tests and laboratory assays conducted by the manufacturer, Industrial Clothings Limited, Prime Polymers Division. These tests would involve:

• Physical Property Testing: Measuring tensile strength and elongation using methods like ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) and ASTM D573 (Standard Test Method for Rubber—Deterioration in an Air Oven). These tests would be performed on samples of the finished gloves, both before and after accelerated aging to simulate shelf life.
• Barrier Integrity Testing: Primarily through the water leak test according to ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves). This involves filling gloves with water and observing for leaks within a specified time, and reporting results based on Acceptable Quality Limits (AQL). An AQL of 2.5 is common for examination gloves, meaning a certain percentage of defects is acceptable. The applicant likely tested to an AQL of 1.5 as is commonly done.
• Biocompatibility Testing: Performing dermal irritation and sensitization tests on Guinea pigs (or other suitable models) according to standards like ASTM F719/F720 or ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization).
• Powder Residue Testing: For powder-free gloves, testing according to ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) to ensure powder levels are below the specified maximum.

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

• Test Set Sample Sizes: The document does not explicitly state the sample sizes used for each test. These details would be contained within the engineering and testing reports submitted as part of the 510(k). For glove testing:
  • For physical properties, sample sizes are usually quite small (e.g., 5-10 gloves per batch per test condition).
  • For the water leak test (AQL testing), sample sizes are determined by statistical sampling plans based on the batch size, as outlined in ASTM D5151 (e.g., ANSI/ASQ Z1.4). For a large batch, this could be hundreds of gloves.
  • For biocompatibility, sample sizes are typically defined by regulatory toxicology guidelines (e.g., 3-5 animals per test group for irritation/sensitization).
• Data Provenance: The manufacturing entity is Industrial Clothings Limited, Prime Polymers Division, located in Sri Lanka. Therefore, the testing data would originate from their facilities or contracted testing laboratories, likely in Sri Lanka or elsewhere as required by testing standards. The data would be prospective as it's generated specifically for the 510(k) submission.

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

This question is not directly applicable in the context of examination gloves. "Ground truth" (in the sense of expert consensus on diagnostic findings) is relevant for diagnostic imaging or AI algorithms. For a physical device like a glove, the "ground truth" is established by adherence to universally accepted engineering and material science standards (e.g., tensile strength values in ASTM, AQL limits in D5151). The "experts" would be the testing technicians, quality engineers, and regulatory specialists who conduct and verify the adherence to these standards. Their qualifications would be expertise in materials testing, quality control, and relevant ASTM/ISO standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (2+1, 3+1) are used for resolving disagreements among multiple human readers on diagnostic tasks, typically in AI/imaging studies. For physical device performance, tests yield objective quantitative or pass/fail results, not subjective interpretations requiring adjudication.

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

Not applicable. MRMC studies compare the performance of human readers (with or without AI assistance) on diagnostic cases. This device is a disposable medical glove, not a diagnostic AI system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device (glove), not an algorithm or AI system.

7. Type of Ground Truth Used

As mentioned, "ground truth" for this device is based on established engineering and material science standards (e.g., ASTM standards) rather than pathology, outcomes data, or expert consensus on clinical findings. For example:

• The "ground truth" for tensile strength is the minimum value specified in the relevant ASTM standard.
• The "ground truth" for barrier integrity is the AQL level specified in ASTM D5151.
• The "ground truth" for biocompatibility is the absence of a significant irritative or sensitizing response according to recognized toxicology protocols.

8. Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning or AI. The term "training set" refers to data used to train an algorithm. For a physical device, the equivalent concept might be the data from process validation runs or initial manufacturing batches used to optimize the production process, but this is distinct from an AI training set.

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

Not applicable for the same reasons as point 8.

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A powder-free 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.

Midas Touch™ - Nitrile Examination Gloves Powder free, Pink

The provided text is a 510(k) premarket notification letter from the FDA for medical gloves, specifically "Midas Touch 101 - Nitrile Examination Gloves-Powder Free, Pink."

This document does not contain information about acceptance criteria and a study proving a device's performance in the sense of an AI/ML or diagnostic device. Instead, it concerns the FDA's determination of substantial equivalence for a patient examination glove to predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as the document does not pertain to such a study or device.

The document primarily focuses on:

• Regulatory Clearance: K122465, indicating the FDA has reviewed the submission and determined substantial equivalence.
• Device Type: Nitrile Examination Gloves, Powder Free, Pink.
• Intended Use: "A powder-free 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."
• Regulatory Classification: Class I, Product Code LZA (Patient Examination Glove).
• Manufacturing Information: Industrial Clothings, Limited, Prime Polymers Division, from Sri Lanka.

For a medical glove, acceptance criteria would typically relate to physical properties (e.g., tensile strength, elongation), barrier integrity (e.g., freedom from pinholes, viral penetration), sterility (if applicable), and biocompatibility. The "study" proving these would be laboratory testing against recognized standards (e.g., ASTM standards for medical gloves). This specific FDA letter, however, only states that substantial equivalence has been determined, implying that such testing was submitted and found acceptable by the FDA, but it does not detail the tests, methodology, or results within the letter itself.

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Midas Touch™ Blue Latex Examination Gloves - Powder free for Chemotherapy use, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner, and for handling and / or preparation of chemotherapeutic drugs.

Midas Touch™ Blue Latex Examination Gloves - Powder free for chemotherapy use

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA letter regarding a 510(k) premarket notification for Midas Touch Blue Latex Examination Gloves, confirming substantial equivalence to a legally marketed predicate device. It discusses regulatory compliance and marketing permissions. Therefore, I cannot fulfill your request based on the given input.

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Midas Touch™ Blue Latex Examination Gloves - Powder free, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Midas Touch™ Blue Latex Examination Gloves – Powder free

The provided text is an FDA 510(k) clearance letter for examination gloves. This type of document does not describe acceptance criteria, study details, or performance metrics for AI/ML-driven devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training or test sets.

The document confirms the device (Midas Touch™ Blue Latex Examination Gloves, Powder Free) is substantially equivalent to legally marketed predicate devices, meaning it meets the general controls provisions for Class I devices. The indications for use are described as: "a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner." This is a regulatory assessment for a physical medical device, not an AI/ML software device.

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Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove, which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Midas Touch™ Purple Nitrile Examination Gloves- Polymer coated, Powder free

This document is a 510(k) clearance letter from the FDA for a medical device, specifically examination gloves. This type of document does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as these are typically found in the 510(k) submission itself, not the clearance letter.

Therefore, I cannot provide the requested information from the provided text. The letter only confirms that the device is substantially equivalent to a predicate device and can be marketed subject to general controls.

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Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free, is a disposable patient examination glove which is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.

Midas Touch™ Latex Examination Gloves- Polymer coated, Powder free WITH PROTEIN LABELING CLAIM (100 mic

The provided text is a 510(k) clearance letter from the FDA for medical examination gloves. It does not describe a study or acceptance criteria for a device in the context of AI/ML performance. Instead, it concerns the substantial equivalence of a physical medical device (gloves) to a predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as these concepts are not applicable to the content of this document.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device