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510(k) Data Aggregation
K Number
K070862Device Name
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE)
Manufacturer
Date Cleared
2007-05-30
(63 days)
Product Code
Regulation Number
880.6250Why did this record match?
Applicant Name (Manufacturer) :
PURTECH CLEANROOM PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Device Description
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power Free Nitrile Examination Gloves (Blue, White), 80 LZA, and meets all requirements of ASTM standard D 6319-00a(2005).
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