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510(k) Data Aggregation
(44 days)
This glove is disposable and intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
PrePowdered Latex Examination Gloves with Protein claim.
This document is a 510(k) premarket notification approval letter for "Pre-Powdered Latex Examination Gloves" from FLEXITECH SDN. BHD. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information from the provided text.
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(43 days)
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(119 days)
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