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510(k) Data Aggregation
K Number
K210868Device Name
Nitrile Examination Gloves Powder Free (Blue)
Manufacturer
Date Cleared
2021-09-02
(163 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Great Eco Glove Sdn. Bhd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Nitrile Examination Gloves Powder Free (Blue) are available in blue color. The proposed device is single use, non-sterile, ambidextrous and meets all the requirements of ASTM Specification D6319-10 (2015) — Standard Specification for Nitrile Examination Gloves for Medical Application.
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