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510(k) Data Aggregation
K Number
K212751Device Name
Powder Free Nitrile Examination Glove
Manufacturer
Date Cleared
2022-09-24
(390 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Dainam Glove Joint Stock Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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
Dainam JSC., Powder Free Gloves 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, non-sterile, single use and disposable and available in size XS-extra small, S-small, M-medium, L-Large, XL- Extra-large.
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