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510(k) Data Aggregation
K Number
K221350Device Name
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Manufacturer
Date Cleared
2022-08-05
(87 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Rubberex Alliance Products Sdn Bhd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Non-sterile 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.
Device Description
The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a 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 gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.
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