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510(k) Data Aggregation
K Number
K163126Device Name
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt blue)
Manufacturer
Date Cleared
2017-02-22
(106 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Blue Sail Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Powder Free Nitrile Examination Gloves (Blue, White, Blue, Cobalt blue) 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.
Device Description
Powder Free Nitrile Examination Gloves (Blue, White, Black, Violet Blue, Cobalt Blue)
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