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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR

This document is a 510(k) clearance letter from the FDA for "Disposable Powdered Vinyl Synthetic Examination Gloves, White Color." It states that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. The letter is an administrative notice of clearance for marketing, not a detailed technical report of device performance testing.

Therefore, I cannot provide the requested information from the given text.

Here's why the information is missing:

• Device Type: This is a Class I medical device (patient examination glove). For such devices, the 510(k) pathway primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.
• Documentation Focus: The provided text is the FDA's clearance letter itself, which summarizes the FDA's decision based on the submitted application. It does not include the detailed technical data, test reports, or study results that would have been submitted by the manufacturer as part of the 510(k) application.
• Nature of Clearance: The 510(k) process for Class I devices often relies on established standards and general controls rather than extensive clinical efficacy studies with specific performance metrics and ground truth establishment as might be required for higher-risk device classifications or AI/software-as-a-medical-device (SaMD) products.

To answer your questions, one would need to review the original 510(k) submission document (K031142) which would contain the performance testing details, if any were required beyond basic physical property tests (e.g., tensile strength, resistance to tearing, barrier integrity).

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E

This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Examination Gloves With Vitamin E". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not describe acceptance criteria for a study, nor does it present the results of a study to prove a device meets acceptance criteria. The structure of the request, with questions about sample size, expert ground truth, adjudication methods, and AI performance, is typically relevant for studies evaluating the performance of AI/ML-driven medical devices or diagnostic tests.

This letter solely concerns the regulatory clearance of a physical medical device (examination gloves), not an AI/ML algorithm or a diagnostic test with performance metrics of the type requested. Therefore, none of the specific questions can be answered from the provided text.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

This document is a 510(k) premarket notification for "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color." It is a regulatory clearance letter from the FDA, and as such, it does not contain information about specific acceptance criteria or a study proving device performance in the way requested.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined it is as safe and effective as a device that was on the market before May 28, 1976, or has been reclassified. This determination is based on the information provided in the 510(k) submission, which typically includes comparisons to a predicate device regarding materials, design, and performance characteristics, but not necessarily a new clinical study with the detailed elements you've requested.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document doesn't detail specific performance metrics or acceptance criteria for the gloves beyond their intended use.
2. Sample size used for the test set and the data provenance: Not applicable, as a new performance study is not detailed.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a medical device (gloves), not an AI algorithm.
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: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on the regulatory aspects of device clearance based on substantial equivalence, rather than detailed performance study results.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR

This document is a 510(k) premarket notification letter from the FDA regarding "Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color." It primarily addresses the substantial equivalence determination for the device. As such, it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be associated with a study demonstrating a device meets acceptance criteria for an AI/CAD system.

The document is for a Class I medical device (patient examination gloves), which typically has much simpler regulatory requirements than more complex devices and certainly does not involve AI or sophisticated image analysis.

Therefore, I cannot provide the requested information from the given text. The provided text does not describe a study that proves a device meets acceptance criteria in the way you've outlined for an AI/CAD system.

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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 fingers to prevent CONTAMINATION BETWEEN PATIENT AND EXAMINER.

ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED

The provided document is a 510(k) premarket notification letter from the FDA for a medical device: "Environ-NP Disposable Vinyl Examination Gloves." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of digital health or AI/ML.

The document is a regulatory approval letter for a physical medical device (gloves), indicating substantial equivalence to a predicate device. It specifies general controls, regulatory classification, and indications for use.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as none of this information is present in the provided text.

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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 FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED

I am sorry, but the provided text only contains information about the FDA's clearance of "ENVIRON-NP Disposable Synthetic Vinyl Examination Gloves, Powdered" and does not include any details regarding acceptance criteria for a study, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The document is a 510(k) clearance letter, which means the device was found substantially equivalent to a legally marketed predicate device, rather than undergoing a new clinical study to establish acceptance criteria based on performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

PVC SYNTHETIC EXAMINATION GLOVES, POWDERED DISPOSABLE

This document is a 510(k) clearance letter from the FDA for "PVC (Polyvinyl Chloride) Synthetic Examination Gloves, Powdered." It is not a study report for a novel medical device like AI software or an implant, but rather a clearance for a relatively simple disposable medical examination glove. Therefore, most of the questions regarding acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert qualifications, MRMC studies, etc.) are not applicable in the typical sense for a 510(k) clearance of this type of device.

For a device like examination gloves, the "acceptance criteria" are generally related to manufacturing standards, material safety, and performance characteristics such as barrier integrity and strength, rather than diagnostic accuracy or clinical outcomes in the same way an AI algorithm would be evaluated. The "study" proving the device meets a criteria would typically involve laboratory testing rather than a clinical trial with human subjects for efficacy.

Here's an attempt to answer the questions based on the provided document and general understanding of 510(k) clearances for examination gloves:

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

The provided document (a 510(k) clearance letter) does not contain a table of acceptance criteria or reported device performance in the same manner as a clinical study report for an AI device. For examination gloves, acceptance criteria are typically derived from recognized consensus standards (e.g., ASTM standards for medical gloves) related to:

• Physical Properties: Tensile strength, elongation at break.
• Barrier Integrity: Freedom from holes (e.g., Water Leak Test, Air Leak Test).
• Dimensions: Length, width, thickness.
• Biocompatibility: Absence of irritation, sensitization, or cytotoxicity (usually tested according to ISO 10993 series).
• Level of Powder (if powdered).

The 510(k) process for examination gloves relies on demonstrating substantial equivalence to a predicate device. This implies that the new device meets the same performance standards as legally marketed predicate devices. The specific quantitative acceptance criteria and the Shanghai Palomar Mountain Industries, Incorporated glove's performance against these criteria are not detailed in this FDA clearance letter. These details would be in the applicant's 510(k) submission.

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

Not applicable directly from the provided document. For physical and barrier integrity testing of gloves, sample sizes are typically determined by statistical sampling plans (e.g., AQL levels for attributes data) from manufacturing batches. The country of origin for the data would be China (where the manufacturer is located), and such testing is generally prospective, occurring during or after manufacturing.

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 examination gloves, "ground truth" is established through standardized laboratory tests (e.g., observing for leaks, measuring tensile strength) by trained technicians or quality control personnel, not subjective expert opinion.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts, which isn't relevant for objective laboratory testing of gloves.

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. MRMC studies are for evaluating diagnostic accuracy with and without AI assistance, which is irrelevant for examination gloves.

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

Not applicable. "Standalone" performance is a concept for AI or automated diagnostic devices. This device is a physical barrier protection device.

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

For examination gloves, the "ground truth" for performance is established by objective, standardized laboratory test methods (e.g., ASTM D6319 for PVC gloves, which specifies tests for physical dimensions, ultimate tensile strength, elongation, and watertight integrity via visual inspection for leaks).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of examination glove evaluation as it's not a machine learning or AI device. Manufacturing processes are honed over time, but this isn't a "training set" in the computational sense.

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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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Vinyl Synthetic Exam Gloves, Powder Free." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving a device's performance in the context of AI, medical imaging, or diagnostic accuracy.

The device in question is a pair of examination gloves, and the approval is based on substantial equivalence to a predicate device, not on a performance study comparing the device to specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria or a performance study from this document. The questions posed are related to the evaluation of AI/software as a medical device, which is not applicable to the product described in the provided text.

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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.

POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED

This document is a 510(k) clearance letter from the FDA for Powdered Blue Nitrile Medical Examination Gloves. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include performance data or studies that would detail acceptance criteria for a device's performance.

Therefore, I cannot extract the requested information from the provided text.

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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.

POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED.

This looks like a letter from the FDA regarding a 510(k) premarket notification for examination gloves, not an AI/ML device or a study related to acceptance criteria.

The document discusses:

• K990299 Powder-Free Copolymer Nitrile Medical Examination Gloves.
• The FDA's determination that the device is substantially equivalent to a predicate device.
• General controls provisions of the Act (annual registration, listing of devices, good manufacturing practice, labeling, etc.).
• Information on labeling regulations, promotion and advertising, and other responsibilities under the Act.
• The "Indications for Use" statement for the gloves, which states they are a disposable device intended for medical purposes to prevent contamination between patient and examiner.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training data for an AI/ML device cannot be extracted from this document, as it is completely unrelated to such a device or study.

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