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510(k) Data Aggregation
K Number
K213227Device Name
Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
Manufacturer
Date Cleared
2022-01-19
(112 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Uweport LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Uweport Powder-Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs is a nonsterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Uweport Powder-Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These powder-free gloves are made of synthetic biocompatible copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are available in small, medium, large, and extra-large.
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