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510(k) Data Aggregation
K Number
K220211Device Name
Nitrile Powder Free Examination Gloves
Date Cleared
2022-05-18
(112 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Hebei kangxida Medical Technology Development Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Nitrile powder free examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. This glove is in blue color, non-sterile and can be available in four specifications: Small, Medium, Large, X meets all of the requirements of ASTM standard D 6139-19.
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