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Found 7 results
510(k) Data Aggregation
(299 days)
A Powder-free pateint 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.
Powder Free Black Nitrile Examination Gloves
The provided document is a 510(k) premarket notification letter from the FDA for Powder Free Black Nitrile Examination Gloves. It primarily discusses the regulatory classification and general controls for the device and confirms its substantial equivalence to a predicate device.
It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or information about AI/ML models.
Therefore, I cannot provide the requested information based on the input text.
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(69 days)
The surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between the patient and the surgeon.
LATEX SURGICAL POWDERFREE GLOVES
This document is a 510(k) clearance letter from the FDA for powder-free latex sterile surgical gloves. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter approves the marketing of the device based on its substantial equivalence to a predicate device. Therefore, I cannot provide the requested information.
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(66 days)
POWDERED NITRILE BLUE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
POWDERED NITRILE BLUE EXAMINATION GLOVES
The provided document is an FDA 510(k) clearance letter for Powdered Nitrile Blue Examination Gloves. It primarily addresses the regulatory approval of the device and its indications for use. The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific ground truth methodologies for evaluating the gloves.
Therefore, I cannot fulfill the request for information on acceptance criteria and supporting studies based on the provided text. The document confirms that the device is "substantially equivalent" to previously marketed devices, which speaks to its regulatory classification rather than detailed performance metrics from a specific study against defined acceptance criteria.
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(89 days)
POWDERED NITRILE EXAMINATION GLOVES ARE WORN ON THE HANDS OF HEALTH CARE AND SIMILAR PERSONNEL TO PREVENT CONTAMINATION BETWEEN HEALTH CARE PERSONNEL AND THE PATIENT.
POWDERED NITRILE EXAMINATION GLOVES
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Powdered Nitrile Examination Gloves", indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classifications, general controls, and good manufacturing practices, but not specific performance acceptance criteria or study details.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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(29 days)
The surgical glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between the patient and the surgeon.
LATEX SURGICAL GLOVE, POWDERED AND STERILE
This document is a 510(k) clearance letter for Powdered Latex Sterile Surgical Gloves. It does not contain information about acceptance criteria, device performance studies, or clinical trial parameters like sample size, ground truth, or expert qualifications. The letter confirms substantial equivalence to a legally marketed predicate device but does not detail the testing used to establish that equivalence.
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(93 days)
The glove is disposable and intended for Medical purpose that is worn on the examiner's hand to prevent contamination between the patient and the examiner.
POWDER FREE BLUE NITRILE GLOVE
The provided document is a 510(k) premarket notification letter from the FDA regarding "Powder Free Blue Nitrile Examination Glove". It primarily confirms that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment for an AI/ML medical device.
The information requested in the prompt (acceptance criteria, study details, expert involvement, etc.) is typically found in the technical documentation of a medical device submission, particularly for AI/ML devices, and is not part of this FDA clearance letter.
Therefore, I cannot extract the requested information from the provided text.
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(62 days)
Latex examination powderfree gloves are worn on the hands of health care and bales examination poracite contamination between health care personnel and the patient.
LATEX EXAMINATION POWDERFREE GLOVES With Protein Labeling Claims (50mg or less)
I am sorry, but the provided text does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device. The document is an FDA 510(k) clearance letter for "TG Medical Powder-Free Latex Examination Glove," which primarily addresses regulatory equivalence to a predicate device. It explicitly states that "this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations."
Therefore, I cannot fulfill your request based on the provided input.
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