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a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Textured Powder-Free Latex Examination Gloves with Protein Labeling Claim (contains 50 micrograms or less of total water extractable protein per gram), Blue Color

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically Textured Powder-Free Latex Examination Gloves. It is not a study report or clinical trial documentation, and therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter primarily:

• Acknowledges the review of the 510(k) submission (K030583).
• States that the device is substantially equivalent to legally marketed predicate devices.
• Grants permission to market the device, subject to general controls.
• Provides information on regulatory compliance.

The second attachment to the letter, titled "INDICATION FOR USE," describes the intended use of the gloves but does not present any performance data or acceptance criteria for evaluation.

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a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is not intended to be used as a chemical barrier.

Textured Powder-Free Latex Examination Gloves with Protein Claim ( Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram), Green Color

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically "Textured Powder-Free Latex Examination Gloves with Protein Claim". It primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification.

The letter does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria. It mentions protein claims (containing 50 micrograms or less of total water extractable protein per gram) but it doesn't describe the testing or study conducted to verify this claim.

Therefore, I cannot provide the requested information based on the provided text.

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A 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 This glove contains 50 micrograms or less of total water extractable Protein per gram.

Powder-Free Patient Examination Glove

This document is a 510(k) clearance letter from the FDA for "Powder-Free Latex Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." It does not describe:

1. Acceptance criteria and reported device performance: The letter states the device is "substantially equivalent" to legally marketed predicate devices, but it does not provide specific acceptance criteria or performance data for the device itself. The protein labeling claim "50 micrograms or less of total water extractable Protein per gram" is an indication for use, not an acceptance criterion with associated test results.
2. Study details for general performance: This document is a regulatory approval, not a scientific study report. It does not contain information about sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. This letter confirms that the device has met the FDA's regulatory requirements for substantial equivalence, which typically means it performs similarly to predicate devices already on the market. The specific testing and data used to establish that equivalence would be in the detailed 510(k) submission, not in this clearance letter.

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The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Latex Examination Gloves ( with Protein Content Labeling Claim ) - GREEN 50 MICROGRAMS, OR LESS

The provided text is related to a 510(k) clearance letter for "Powder Free Latex Examination Gloves (with Protein Content Labeling Claim) - GREEN 50 MICROGRAMS, OR LESS". This document itself does not contain the acceptance criteria or a study proving the device meets those criteria, as typically found in a scientific or clinical study report.

Instead, this is a regulatory letter confirming that the device is "substantially equivalent" to predicate devices already on the market. This substantial equivalence determination is based on the information submitted by the manufacturer in their 510(k) notification.

Therefore, I cannot extract the requested information as it is not present in the provided document. The questions you asked are generally applicable to the evaluation of a new medical device through clinical trials or performance studies, which are typically summarized in a different kind of document than a 510(k) clearance letter.

To answer your request based on the provided text, I can only state that this document does not contain the information required to construct the table or answer the specific questions about acceptance criteria and study details.

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