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510(k) Data Aggregation
K Number
K130101Device Name
BYTECH
Manufacturer
Date Cleared
2013-11-08
(297 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
BYTECH DONGTAI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Powder Free Viny| Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material , intended for medical purpose that worn on examiner's hand or linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
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