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510(k) Data Aggregation
K Number
K212308Device Name
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
Manufacturer
Date Cleared
2021-10-29
(98 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Srirungruang Global Co., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free
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