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510(k) Data Aggregation
K Number
K212716Device Name
Dermoaroma Disposable Nitrile Examination Glove
Date Cleared
2021-12-27
(122 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
ChuZhou Harmony Gloves Medical Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Dermoaroma Disposable Nitrile Examination Gloveare disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Device Description
The proposed device is Powder Free Dermoaroma Disposable Nitrile Examination Glove. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
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