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510(k) Data Aggregation
K Number
K230542Device Name
Disposable Nitrile Gloves (ABC-DG01)
Manufacturer
Date Cleared
2023-05-31
(92 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Huizhou Anboson Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Device Description
The Disposable Nitrile Gloves are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue or black color, powder free, nitrile ambidextrous gloves. The gloves are offered in large (L) size, packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard.
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