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510(k) Data Aggregation
K Number
K212485Device Name
Disposable Nitrile Examination gloves
Date Cleared
2021-11-05
(88 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Fujian Yuanxin Safety Protection Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Nitrile Examination gloves are 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 Disposable Nitrile Examination gloves. 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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