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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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