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A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Master Guard Disposable Nitrile Powdered Blue Examination Gloves

This FDA 510(k) clearance letter for "Master Guard Disposable Nitrile Powdered Blue Examination Gloves" does not contain the detailed information necessary to describe acceptance criteria and a study proving device performance in the way requested.

The letter primarily focuses on the regulatory determination of substantial equivalence to a predicate device, which means the device is considered as safe and effective as a legally marketed device that was on the market prior to May 28, 1976.

Specifically, the document does not provide any information for the following requested items:

1. A table of acceptance criteria and the reported device performance: This type of data is typically found in a summary of safety and effectiveness or a test report, not in the clearance letter itself.
2. Sample size used for the test set and the data provenance: There is no mention of specific test sets or their size/origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable, as no such test is described.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable (this is a physical glove, not an AI algorithm).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is a physical glove, not an AI algorithm).
9. How the ground truth for the training set was established: Not applicable.

The document does state the Indications for Use:
"A patient examination Nitrile Blue Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."

To find information on acceptance criteria and performance data for this type of device, one would typically need to refer to:

• Voluntary consensus standards: Such as ASTM standards for medical examination gloves (e.g., ASTM D6319 for nitrile examination gloves), which define performance requirements for properties like tensile strength, elongation, puncture resistance, and barrier integrity (e.g., AQL for pinholes).
• The 510(k) submission itself: The actual submission would contain the test reports and data that demonstrate the device meets these standards and any other specific performance claims, enabling the FDA to determine substantial equivalence.

Without access to the actual 510(k) submission, the requested information cannot be extracted from the provided text.

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A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powder Free Examination Glove

Here's an analysis of the provided FDA document regarding the acceptance criteria and study details for the Nitrile Blue Powder Free Examination Glove:

This document is a 510(k) clearance letter for a medical device (Nitrile Blue Powder Free Examination Glove). It does not contain the acceptance criteria or results of a study designed to prove the device meets specific performance criteria, especially not in the context of an AI/ML powered device.

Instead, this document is a regulatory approval letter stating that the device is "substantially equivalent" to a legally marketed predicate device. This means the manufacturer demonstrated that their device performs similarly to an existing device for its intended use, rather than conducting a de novo study against a set of predefined acceptance criteria for novel performance claims.

Therefore, I cannot provide the requested information from the provided text. The questions you've asked are typically relevant for AI/ML device submissions, which involve rigorous testing against performance metrics. This document pertains to a Class I medical device for which the primary regulatory pathway is demonstrating substantial equivalence.

However, to illustrate what specific elements are missing and why the provided document does not fulfill the request, let's address each point as if this were an AI/ML device submission, explaining why the information is absent:

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

• Missing: This document does not specify any quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1 score, AUC) or corresponding acceptance criteria needed for an AI/ML device. For a glove, the "performance" would relate to barrier integrity, tensile strength, and freedom from holes, but these types of metrics are not detailed here.

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

• Missing: No test set is described, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm.

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)

• Missing: Not applicable for this type of device and submission.

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

• Missing: 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

• Missing: Not applicable. This device is not an AI algorithm intended to assist human readers.

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

• Missing: Not applicable. This is a physical product, not an algorithm.

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

• Missing: Not applicable. For a glove, "ground truth" might relate to physical properties meeting standards, but this is not detailed.

8. The sample size for the training set

• Missing: Not applicable. There is no training set for a physical device like a glove.

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

• Missing: Not applicable.

Conclusion:

The provided FDA letter (K071208) is a clearance for a Nitrile Blue Powder Free Examination Glove based on substantial equivalence. It does not contain the detailed performance metrics, study designs, or data provenance information that would be requested for an AI/ML device's acceptance criteria and validation study. The letter confirms market clearance, but not specific test results or acceptance criteria in the manner you've outlined for software/algorithm performance.

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A patient examination Latex Powder Free Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Powder Free Examination Gloves

This document is an FDA 510(k) clearance letter for "Latex Powder Free Examination Gloves". It does not contain information about acceptance criteria and a study proving a device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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A patient examination Latex Powdered Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Latex Powdered Examination Glove

The provided text is a 510(k) premarket notification letter from the FDA to High Momentum SDN. BHD. regarding a Latex Powdered Examination Glove. It primarily addresses the substantial equivalence determination for the device, and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on equivalence to a predicate device, not on detailed performance study results against specific criteria.

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