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510(k) Data Aggregation
K Number
K221108Device Name
Nitrile Medical Examination Gloves
Manufacturer
Date Cleared
2022-07-12
(88 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Anhui Fulewei Electronic Technology Co.,Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Nitrile Medical Examination Gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
Nitrile Medical Examination Gloves is a patient examination glove and it is made from nitrile compound. It is a single-use, powder-free and non-sterile product. The glove is worn on the examiner's hand to prevent contamination between patient and examiner, and this device meets all the requirement specifications in the ASTM D6319-19 Standard.
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