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510(k) Data Aggregation
K Number
K212898Device Name
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs
Manufacturer
Date Cleared
2021-12-16
(97 days)
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Rimba Glove SND BHD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs per ASTM D6978-05(2019) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Description
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile Tested for use with Chemotherapy Drugs meet all requirements of ASTM standard D6319 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.
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