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Found 6 results
510(k) Data Aggregation
(97 days)
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)
A Vinyl examination glove, Powder Free, Clear (Non-Colored) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Stretch Vinyl Examination Glove, Powder Free (Yellow/White/Clear (non-colored)
The provided text is a letter from the FDA regarding the 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications as requested in the prompt.
Therefore, I cannot extract the requested information from the provided text.
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(193 days)
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE
The Stretch Vinyl examination glove, Powder Free, Yellow/White 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, Stretch Vinyl Examination Gloves, Yellow/White
This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria, as such information would typically be found in the 510(k) submission itself or in a separate performance study report, not in the clearance letter.
Therefore, I cannot provide the requested details based on the provided text.
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(78 days)
NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
A Stretch Vinyl examination glove(Yellow/white) 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, Stretch Vinyl Examination Gloves, Yellow/White
The provided text is a 510(k) premarket notification letter from the FDA to Novapro Company, Limited regarding their Powder-Free, Stretch Vinyl Examination Gloves, Yellow/White. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/device study.
The letter is an approval for a medical device (examination gloves) based on a determination of substantial equivalence to legally marketed predicate devices, not on the results of a specific performance study in the way one would describe for an AI/diagnostic device.
Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided input.
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(81 days)
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE)
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(182 days)
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
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(21 days)
VINYL EXAMINATION GLOVE, POWDER-FREE, YELLOW
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