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510(k) Data Aggregation
K Number
K202081Device Name
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, BlueManufacturer
Date Cleared
2021-03-19
(235 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
Not Found
AI/ML Overview
I'm sorry, but this document contains a letter regarding medical device clearance (K202081) for "Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue." It discusses regulatory aspects, such as compliance with FDA regulations (21 CFR 880.6250), labeling, and reporting requirements.
However, this document does not contain any information about an AI/ML device, its acceptance criteria, or the study proving its performance. Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.
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