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A Powder-Free Patient Examination Glove 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.

Non-Sterile, Powder-Free Blue Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or less) Non-Sterile, Powder-Free Blue Latex Examination Gloves with Bubble Gum Scent and Protein Labeling Claim (50 Micrograms or less) Non-Sterile, Powder-Free Blue Latex Examination Gloves with Grape Scent and Protein Labeling Claim (50 Micrograms or less)

This is a 510(k) premarket notification for examination gloves. The document primarily focuses on regulatory approval based on demonstrating "substantial equivalence" to a predicate device, rather than providing a detailed study report with acceptance criteria and performance data for a novel device or AI algorithm.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, training set details) is not applicable or not provided in the given text because this document is describing the regulatory approval of a medical device (examination gloves) based on substantial equivalence, not a study performing to acceptance criteria of a novel device.

Here's what can be extracted based on the nature of the device (examination gloves) and the provided text:

• Device Name: Non-Sterile, Powder-Free Blue Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms or less); Non-Sterile, Powder-Free Blue Latex Examination Gloves with Bubble Gum Scent and Protein Labeling Claim (50 Micrograms or less); Non-Sterile, Powder-Free Blue Latex Examination Gloves with Grape Scent and Protein Labeling Claim (50 Micrograms or less)
• Regulation Number: 21 CFR 880.6250
• Regulation Name: Patient Examination Glove
• Regulatory Class: I
• Product Code: LYY
• Indication For Use: A Powder-Free Patient Examination Glove 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.

Regarding the protein content labeling claim (50 micrograms or less), this likely refers to a performance characteristic that would have acceptance criteria for the device if a new device were being tested for this claim. However, the provided text does not describe an independent study to prove this claim, but rather the regulatory approval process which would typically rely on manufacturer data and comparison to predicate devices that also meet such claims.

Summary based on the input:

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

   • Not provided. The document is a regulatory approval letter based on substantial equivalence, not a detailed study report. The mention of "Protein Content Labeling Claim (50 Micrograms or less)" implies a performance target, but no specific acceptance criteria or reported performance data from a study is presented in this document.

2. Sample sized used for the test set and the data provenance:

   • Not applicable/Not provided. This document does not describe a performance study for the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided. Ground truth establishment is not relevant for the regulatory approval of examination gloves based on substantial equivalence.

4. Adjudication method for the test set:

   • Not applicable/Not provided.

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 not an AI-assisted device.

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

   • Not applicable. This is not an algorithm.

7. The type of ground truth used:

   • Not applicable/Not provided.

8. The sample size for the training set:

   • Not applicable/Not provided.

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

   • Not applicable/Not provided.

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A NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVE WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN LABELING CLAIM (50 micrograms or less) 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.

NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES, WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN CONTENT LABELING CLAIM (50 Micrograms or Less)

This document is a 510(k) premarket notification acceptance letter for latex examination gloves, not a study describing the acceptance criteria and performance of a device. Therefore, I cannot extract the requested information like sample sizes, expert qualifications, or details about comparative effectiveness studies.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new premarket approval application (PMA). The notification simply states the "Indications for Use" for the gloves:

Indications for Use:
"A NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVE WITH AND/OR WITHOUT STRAWBERRY SCENT, AND WITH PROTEIN LABELING CLAIM (50 micrograms or less) 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 type of document does not contain the specific performance metrics or study details you are asking for. It's an administrative approval based on demonstrating equivalence, not a detailed report of a study validating acceptance criteria.

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

CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT (50 MICROGRAMS OR LESS)

This document is a 510(k) premarket notification decision letter from the FDA to Oon Corporation Resources (M) Sdn. Bhd. regarding "Powder-Free (Chlorinated) Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms Or Less)."

This letter approves the device for marketing due to its substantial equivalence to legally marketed predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance data beyond the device's labeling claim of "50 Micrograms Or Less" for protein content.

Therefore, I cannot provide the requested information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert information because:

• Acceptance Criteria and Reported Device Performance: These are not explicitly stated in the provided text. The letter only mentions a "Protein Content Labeling Claim (50 Micrograms Or Less)," which implies a performance characteristic but doesn't define formal acceptance criteria against a specific standard or test.
• Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set size, training ground truth): The document is a regulatory approval letter based on an application, not the study report itself. It does not describe the specific studies or data submitted by the manufacturer to support their claims. It only confirms the FDA's review and determination of substantial equivalence.

In summary, the provided text confirms the regulatory status of the device but lacks the detailed scientific study information requested.

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IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON-THE EXAMINER*S WAND TO PREVENT CONTAMINATION™ BETWEEN PATIENT AND EXAMINER.

POWDER-FREE LATEX EXAMINATION GLOVES

The provided text is a 510(k) premarket notification letter from the FDA regarding "Latex Examination Gloves, Powderfree." This document is a regulatory approval letter and does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the given input. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail performance acceptance criteria or a study's findings.

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