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A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

A Powder Free Patient Examination Glove is a Disposable Device made of Natural Rubber -Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

The provided text is a 510(k) premarket notification letter from the FDA to Kanam Latex Industries PVT. Limited for "Powder Free Latex Sterile Patient Examination Gloves." The document confirms substantial equivalence but does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in detailed performance reports for more complex medical devices.

The device in question, "Powder Free Latex Sterile Patient Examination Gloves," is a Class I medical device. For such devices, the FDA typically assesses substantial equivalence primarily based on comparison to a legally marketed predicate device rather than requiring extensive clinical studies with specific performance metrics and acceptance criteria in the same way as, for example, an AI diagnostic tool.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or not present in this type of FDA document for this specific device.

Here's the breakdown of why the information is not present and what can be inferred:

1. A table of acceptance criteria and the reported device performance: Not provided. For gloves, acceptance criteria usually relate to physical properties (tensile strength, elongation, barrier integrity, sterility), absence of powders, and biocompatibility. These are typically tested against recognized consensus standards (e.g., ASTM standards) rather than clinical performance metrics in a study report summarized in a 510(k) letter. The letter states the device is "substantially equivalent" to predicate devices, implying it meets similar performance and safety standards.

2. Sample sized used for the test set and the data provenance: Not provided. Performance testing for gloves would involve laboratory testing of physical and chemical properties from a sample of gloves. The letter does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic devices (e.g., expert consensus on images) is not relevant for examination gloves. Performance is assessed through standardized laboratory tests.

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 is for AI-assisted diagnostic devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI or software-as-a-medical-device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic performance. For gloves, "ground truth" would be the objective measurements from laboratory tests (e.g., burst pressure, freedom from holes, protein content).

8. The sample size for the training set: Not applicable. This device does not involve AI or machine learning that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The FDA letter confirms that the "Powder Free Latex Sterile Patient Examination Gloves" (K052728) are substantially equivalent to legally marketed predicate devices. This determination is based on the device meeting the same indications for use and having similar technological characteristics, which would include compliance with relevant performance standards for examination gloves. The specific details of performance testing, sample sizes, and ground truth establishment (as relevant for non-AI diagnostic devices) are not included in this high-level regulatory clearance letter.

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A Powdered Patient Examination Glove is a Disposable Device made of Natural Rubber Latex and is intended to be worn on the hands, for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

PRE-POWDERED LATEX STERILE PATIENT EXAMINATION GLOVES

The provided text is a 510(k) premarket notification letter from the FDA to Kana Latex Industries Pvt. Ltd. regarding "Pre-Powdered Sterile Examination Gloves." This document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory approval document, affirming that the device is "substantially equivalent" to legally marketed predicate devices. It discusses regulatory compliance, labeling, and other general controls under the Food, Drug, and Cosmetic Act.

Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study information, or expert ground truth based on the provided input.

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The Polymer coated, Powderfree Sterile Surgeon's Glove is to be worn by Operating Room Personnel to protect a Surgical Would from contamination.

POWDERFREE LATEX SURGEON'S GLOVES POLYMER COATED STERILE Contains 50 micrograms or less of Total water extractable protein per gram

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding "Powder Free Latex Surgeon's Gloves Polymer Coated Sterile". This document is a regulatory approval for a physical medical device (gloves) and does not contain information about a digital medical device, AI, or any study involving acceptance criteria and performance data in the context you've described.

Therefore, I cannot extract the information required in your request about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies for a digital medical device from the given text.

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A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination.

Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification approval letter for Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less), manufactured by Kanam Latex Industries PVT. Limited.

This is not a study report for a device performance, but rather an FDA approval for marketing the product based on its substantial equivalence to a legally marketed predicate device. Therefore, the detailed information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not present in the provided text.

The document only states that the device is "substantially equivalent" to predicate devices for its stated indications for use.

Here's what can be extracted and what cannot be from the provided text:

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

• Not available. The document does not provide a table of acceptance criteria or specific performance metrics for the Kanam Latex Surgeon's Gloves. It only states that the device is "substantially equivalent" to legally marketed predicate devices. The "Protein Contact Labeling Claim (50 Micrograms or Less)" implies a specific characteristic, but no performance data against this claim is provided.

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

• Not available. The document does not mention any sample sizes for test sets or data provenance. The approval is based on substantial equivalence, not a detailed performance study presented in this 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 available. This information is irrelevant to a 510(k) substantial equivalence determination. No ground truth establishment for a test set is discussed.

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

• Not available. No test set or adjudication method is described in this regulatory letter.

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 / Not available. This device is a surgical glove, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.

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

• Not applicable / Not available. This device is a physical product (surgical gloves), not an algorithm.

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

• Not available. The concept of "ground truth" as typically applied to performance studies of diagnostic or AI devices is not relevant to this 510(k) submission for surgical gloves. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set:

• Not applicable / Not available. As this is a physical medical device (surgical gloves) and not a machine learning algorithm, there is no "training set."

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

• Not applicable / Not available. As there is no training set, this information is not applicable.

Summary from the document:

• Device Name: Powder Free Latex Surgeon's Gloves with Protein Contact Labeling Claim (50 Micrograms or Less)
• Manufacturer: Kanam Latex Industries PVT. Limited (India)
• Regulatory Class: I
• Product Code: KGO
• Indication for Use: "A Powder - free surgeon's glove is a disposable device made of natural latex that may bear a trace amount of glove powder but not more than 2 milligrams per glove may bour a trace anounces on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contamination."
• Approval Basis: Substantial equivalence to legally marketed predicate devices.
• Approval Date: February 6, 2002

To obtain the detailed study information as requested, one would need to refer to the actual 510(k) summary submitted by Kanam Latex Industries PVT. Limited, which often contains details of biocompatibility testing, protein content testing, and other performance studies demonstrating substantial equivalence. This letter is merely the FDA's decision based on that submission.

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