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510(k) Data Aggregation
K Number
K220284Device Name
Powder Free Nitrile Examination Gloves (Blue)
Manufacturer
Date Cleared
2022-07-08
(157 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
KGM Gloves Sdn. 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 hands or fingers to prevent contamination between patient and examiner.
Device Description
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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