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510(k) Data Aggregation
K Number
K223280Device Name
Disposible Nitrile Gloves
Manufacturer
Date Cleared
2023-05-08
(196 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
HOLIK ASIA GROUP CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable nitrile gloves are intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Device Description
The Disposable nitrile gloves are powder free nitrile examination gloves. The Disposable nitrile gloves will be provided in blue. It can be available in four specifications: S,M,L and XL. And it is non-sterile.
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