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This product is a powder free patient examination glove with 50 Micrograms or less of latex protein. It 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.

Powder Free Latex Examination Gloves with Protein Labelling Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification from the FDA, and it does not contain the detailed information about acceptance criteria and study results typically found in a clinical study report or a premarket approval (PMA) application. It focuses on the substantial equivalence of the device (Cranberry Powder-Free Latex Examination Gloves with Protein Content Labeling Claim) to a predicate device.

Therefore, I cannot provide answers to most of your questions based solely on the provided text. The document does not describe the specific testing or studies performed to demonstrate the "50 Microgram or Less" protein content claim or other performance criteria.

However, I can extract the following limited information:

• Device Name: Cranberry Powder-Free Latex Examination Gloves with Protein Content Labeling Claim (50 Microgram or Less)
• Product Code: LYY
• Indications For Use: "This product is a powder free patient examination glove with 50 Micrograms or less of latex protein. It 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." This indication explicitly includes the protein content claim of "50 Micrograms or less," which functions as a performance acceptance criterion for the device's labeling claim.

To answer your full set of questions, one would need to consult the actual 510(k) submission document, which would include the testing protocols and results that support the claims made about the device, particularly the protein content.

In summary, based on the provided text, I can only state that a key performance claim, and therefore a de-facto acceptance criterion for labeling, is a latex protein content of "50 Micrograms or less." The document does not include a study description, sample sizes, expert details, or other specifics of how this criterion was met.

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This product is a patient examination glove. It 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.

Nitrile Powder Free Examination Glove - Cranberry

This document is a 510(k) premarket notification decision letter from the FDA for Nitrile Powder-Free Examination Gloves. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of the requested AI/medical device study information.

The document indicates that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It pertains to a physical medical device (examination gloves) and not an AI/software as a medical device.

Therefore, I cannot provide the requested information such as:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is a physical device clearance based on substantial equivalence, not performance metrics against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone 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.

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