Search Results
Found 19 results
510(k) Data Aggregation
(51 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Latex Examination Gloves (Polymer Coated) (Protein Label Claim) 50
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "Powderfree Latex Examination Gloves (Polymer Coated)". This document does not contain any information about acceptance criteria, device performance studies, or details regarding AI systems.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input, as this information is not present in the document.
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(50 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to pervent contamination between patient and examiner.
Powderfree Latex Examination Gloves (Protein Label Claim) C 50mcg of
This document is an FDA 510(k) clearance letter for "Powderfree Latex Examination Gloves (Protein Trade Name: Label Claim)." It is not a study that evaluates a medical device against acceptance criteria using performance data. Therefore, I cannot extract the requested information.
The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. It does not contain any details about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.
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(28 days)
A patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Latex Examination Gloves (Protein Trade Name: Label Claim) [150 Micrograms or Less]
This document is a 510(k) clearance letter from the FDA for "Powdered Latex Examination Gloves (Protein Trade Name: Label Claim) [150 Micrograms or Less]". It addresses the regulatory classification and substantial equivalence of the device but does not contain information about acceptance criteria, study details, or device performance metrics as requested.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance data.
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(33 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Green Nitrile Examination Gloves (Polymer Coated)
The provided document is a 510(k) clearance letter from the FDA for Powderfree Green Nitrile Examination Gloves. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria as typically found in an AI/Software as a Medical Device (SaMD) submission. The document primarily focuses on clearing the device based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information from this document. If you have a different document that details acceptance criteria and performance studies for an AI/SaMD, please provide it.
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(35 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Green Latex Examination Gloves ( Polymer Coated )
This is an FDA Premarket Notification (510(k)) for "Powderfree Latex Examination Gloves (Polymer Coated)". This document is an approval letter and does not contain details about acceptance criteria or a study proving device performance.
Therefore, I cannot extract the requested information from the provided text.
Ask a specific question about this device
(35 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Green Latex Examination Gloves
I'm sorry, but I cannot fulfill your request. The provided text is a letter from the FDA regarding a 510(k) premarket notification for "Powderfree Green Latex Examination Gloves." It confirms the device's substantial equivalence to a predicate device and allows it to be marketed.
This document does not contain any information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone). These are typically found in the 510(k) summary or detailed test reports, not in the FDA's clearance letter itself.
Therefore, I cannot extract the requested information from the provided text.
Ask a specific question about this device
(35 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Green Latex Examination Gloves
This document is a 510(k) clearance letter from the FDA for "Powdered Green Latex Examination Gloves." This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.
The 510(k) process is about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving specific performance metrics against pre-defined acceptance criteria through a detailed study like one would find for a novel or high-risk device.
Therefore, I cannot provide the requested information based on this document.
Ask a specific question about this device
(31 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered Green Nitrile Examination Gloves
This document is an FDA 510(k) clearance letter for Powdered Green Nitrile Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance, and therefore, the requested table and study details cannot be extracted from the provided text.
The document states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This determination is based on the device's indications for use and compliance with general controls provisions of the Act, including good manufacturing practices.
To answer your request, information about performance testing (such as barrier integrity, strength, biocompatibility, etc.) would need to be present in the original 510(k) submission, which is not provided here.
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(30 days)
Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powderfree Green Nitrile Examination Gloves
This document is a letter from the FDA regarding a 510(k) premarket notification for "Powderfree Green Nitrile Examination Gloves." It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies of an AI device.
Therefore, I cannot fulfill the request as the provided text pertains to regulatory approval for medical gloves and not to the evaluation of a medical device using the specified metrics.
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(42 days)
A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Safety Powderfree Blue Latex Examination Gloves (Polymer Coated)
This document is a 510(k) clearance letter from the FDA for medical gloves. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Therefore, I cannot provide the requested information based on the provided text.
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