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510(k) Data Aggregation
(48 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.
The document is a letter from the FDA to a medical device manufacturer, stating that their "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color" have been found substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements for marketing the device.
Therefore, I cannot provide the requested information about acceptance criteria and a study to prove they are met based on this text.
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(21 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER, TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
The provided text is a 510(k) substantial equivalence determination letter from the FDA for "Disposable Vinyl Synthetic Examination Gloves, Powder Free". This document is a regulatory approval and does not contain information about acceptance criteria or a study proving that a device meets those criteria for software or AI medical devices.
The document discusses:
- The device name and its regulatory classification.
- The FDA's determination that the device is substantially equivalent to a legally marketed predicate device.
- General controls and requirements under the Federal Food, Drug, and Cosmetic Act.
- Indications for Use for the gloves (to prevent contamination between patient and examiner).
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions posed pertain to the analytical validation of AI/ML or complex diagnostics, which is a different type of submission and data than what is found in this specific 510(k) clearance letter for examination gloves.
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