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510(k) Data Aggregation
K Number
K203191Device Name
LYDUS Nitrile Examination Gloves, Powder Free
Manufacturer
Date Cleared
2021-02-12
(108 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
Nathan Trading Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Device Description
The subject device in this 510(k) Notification is LYDUS Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
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